Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04126200 |
Recruitment Status :
Recruiting
First Posted : October 15, 2019
Last Update Posted : September 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Belantamab mafodotin Drug: GSK3174998 Drug: Feladilimab Drug: Nirogacestat Drug: Dostarlimab Drug: Isatuximab Drug: Lenalidomide Drug: Dexamethasone Drug: Pomalidomide | Phase 1 Phase 2 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 464 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | There will be a dose exploration (DE) phase which will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with other anti-cancer treatments. A recommended Phase 2 dose (RP2D) for each combination treatment will be identified based on the safety and preliminary efficacy in DE. This will be followed by a cohort expansion (CE) phase which will evaluate the clinical activity of the combination treatment in comparison to belantamab mafodotin monotherapy in additional participants. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5 |
Actual Study Start Date : | October 7, 2019 |
Estimated Primary Completion Date : | February 21, 2025 |
Estimated Study Completion Date : | February 23, 2028 |

Arm | Intervention/treatment |
---|---|
Experimental: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: GSK3174998 GSK3174998 will be administered |
Experimental: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Feladilimab feladilimab will be administered. |
Experimental: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Nirogacestat Nirogacestat will be administered |
Experimental: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Dostarlimab Dostarlimab will be administered. |
Experimental: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Isatuximab Isatuximab will be administered |
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Lenalidomide Lenalidomide will be administered Drug: Dexamethasone Dexamethasone will be administered |
Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Dexamethasone Dexamethasone will be administered Drug: Pomalidomide Pomalidomide will be administered |
Active Comparator: Belantamab mafodotin monotherapy cohort expansion |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered |
Experimental: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: GSK3174998 GSK3174998 will be administered |
Experimental: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Feladilimab feladilimab will be administered. |
Experimental: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Nirogacestat Nirogacestat will be administered |
Experimental: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Dostarlimab Dostarlimab will be administered. |
Experimental: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Isatuximab Isatuximab will be administered |
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Lenalidomide Lenalidomide will be administered Drug: Dexamethasone Dexamethasone will be administered |
Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7) |
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered Drug: Dexamethasone Dexamethasone will be administered Drug: Pomalidomide Pomalidomide will be administered |
- DE Phase: Number of participants achieving dose limiting toxicities (DLT) [ Time Frame: Up to 12 months ]An event is considered to be a dose DLT if the event occurs within the first 21 days of treatment and meets the dose limiting toxicity criteria.
- DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 12 months ]AEs and SAEs will be collected.
- DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters [ Time Frame: Up to 12 months ]Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.
- CE Phase: Number of participants achieving Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]ORR is defined as the percentage of participants with a Partial response (PR) or better, according to the International Myeloma Working Group (IMWG) Response Criteria.
- DE Phase: Number of participants achieving ORR [ Time Frame: Up to 12 months ]ORR is defined as the percentage of participants with PR or better, according to the IMWG Response Criteria.
- CE Phase: Number of participants achieving Clinical Benefit Rate (CBR) [ Time Frame: Up to 36 months ]CBR is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.
- DE Phase: Number of participants achieving Partial Response (PR) [ Time Frame: Up to 12 months ]Number of participants with PR according to IMWG criteria will be analyzed.
- CE Phase: Number of participants achieving PR [ Time Frame: Up to 36 months ]Number of participants with PR according to IMWG criteria will be analyzed.
- DE Phase: Number of participants achieving Very Good Partial Response (VGPR) [ Time Frame: Up to 12 months ]Number of participants with VGPR according to IMWG criteria will be analyzed.
- CE Phase: Number of participants achieving VGPR [ Time Frame: Up to 36 months ]Number of participants with VGPR according to IMWG criteria will be analyzed.
- DE Phase: Number of participants achieving Complete Response (CR) [ Time Frame: Up to 12 months ]Participants with CR according to IMWG criteria will be analyzed.
- CE Phase: Number of participants achieving CR [ Time Frame: Up to 36 months ]Participants with CR according to IMWG criteria will be analyzed.
- DE Phase: Number of participants achieving stringent Complete Response (sCR) [ Time Frame: Up to 12 months ]Participants with sCR according to IMWG criteria will be analyzed.
- CE Phase: Number of participants achieving sCR [ Time Frame: Up to 36 months ]Participants with sCR according to IMWG criteria will be analyzed.
- DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of belantamab mafodotin.
- CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of belantamab mafodotin.
- DE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of GSK3174998.
- CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of GSK3174998.
- DE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of feladilimab.
- CE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of feladilimab.
- DE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of nirogacestat.
- CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of nirogacestat.
- DE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of dostarlimab.
- CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of dostarlimab.
- DE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples will be collected for concentrations of isatuximab.
- CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples will be collected for concentrations of isatuximab.
- DE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments [ Time Frame: Up to 12 months ]Blood samples for concentrations for ADAs will be collected.
- CE Phase: Concentration of ADAs against belantamab mafodotin when administered in combination with anti-cancer treatments [ Time Frame: Up to 36 months ]Blood samples for concentrations for ADAs will be collected.
- DE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples for concentrations for ADAs will be collected.
- CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples for concentrations for ADAs will be collected.
- DE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples for concentrations for ADAs will be collected.
- CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples for concentrations for ADAs will be collected.
- DE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples for concentrations for ADAs will be collected.
- CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples for concentrations for ADAs will be collected.
- DE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin [ Time Frame: Up to 12 months ]Blood samples for concentrations for ADAs will be collected.
- CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin [ Time Frame: Up to 36 months ]Blood samples for concentrations for ADAs will be collected.
- DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for belantamab mafodotin [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with AESI for GSK3174998 [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for GSK3174998 [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with AESI for Feladilimab [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for Feladilimab [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with AESI for Nirogacestat [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for Nirogacestat [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with AESI for Dostarlimab [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for Dostarlimab [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with AESI for Isatuximab [ Time Frame: Up to 12 months ]AESIs will be collected.
- CE Phase: Number of participants with AESI for Isatuximab [ Time Frame: Up to 36 months ]AESIs will be collected.
- DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination [ Time Frame: Up to 12 months ]Ophthalmic examination will assess abnormal findings.
- CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination [ Time Frame: Up to 36 months ]Ophthalmic examination will assess abnormal findings.
- CE Phase: Number of participants achieving Progression-free survival (PFS) [ Time Frame: Up to 36 months ]PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
- CE Phase: Duration of response (DoR) [ Time Frame: Up to 36 months ]DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
- CE Phase: Time to response (TTR) [ Time Frame: Up to 36 months ]TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
- CE Phase: Number of participants achieving Overall survival (OS) [ Time Frame: Up to 36 months ]OS is defined as the time from randomization until death due to any cause.
- CE Phase: Number of participants with AEs and SAEs [ Time Frame: Up to 36 months ]AEs and SAEs will be collected.
- CE Phase: Number of participants with AEs leading to discontinuation [ Time Frame: Up to 36 months ]Number of participants with AEs leading to discontinuation will be evaluated.
- CE Phase: Number of participants with dose reduction or delay [ Time Frame: Up to 36 months ]Number of participants with dose reduction or delay will be evaluated.
- CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters [ Time Frame: Up to 36 months ]Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
- Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
- Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunodilating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
- Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
- Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 mg per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
- Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV DNA undetectable during screening.
- Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.
Inclusion Criteria Specific to Sub-study 6 and 7:
- Participants with contraception requirements specific to Sub-study 6 and 7 respectively.
- Participants with platelets value for Adequate Organ System Function is ≥75 × 10^9/L.
Exclusion Criteria:
- Participants with current corneal epithelial disease except mild punctate keratopathy.
- Participants with evidence of cardiovascular risk
- Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
- Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
- Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
- Participants with prior radiotherapy within 2 weeks of start of study therapy.
- Participants with prior allogeneic transplant are prohibited.
- Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
- Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
- Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
- Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
- Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
- Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
- Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
Additional Exclusion Criteria for Sub-study 1 and Sub-study 2:
- Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
- Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.
Additional Exclusion Criteria for Sub-study 3, 6 & 7:
- Participants with uncontrolled small and/or large intestinal disease.
- Participants with uncontrolled skin disease.
- Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.
- Participants with previous administration of a gamma secretase inhibitor.
- Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.
Additional Exclusion Criteria for Sub-study 4:
- Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Participants who have received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.
Additional Exclusion Criteria for Sub-study 5:
- Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its excipients.
- Participants with prior treatment with other anti-CD38 monoclonal antibody within 6 months of the first dose of study drug treatment.
- Participants with known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80.
Additional Exclusion Criteria for Sub-study 6 and 7:
- Participants with active or history of venous thromboembolism within the past 3 months.
- Participants with evidence of active mucosal or internal bleeding
- Participants with contraindications to or are unwilling to undergo protocol-required anti-thrombotic prophylaxis or unable to tolerate antithrombolitic prophalaxis,
Additional Exclusion Criteria for Sub-study 6:
- Participants who discontinued prior treatment with lenalidomide due to intolerable adverse events
Additional Exclusion Criteria for Sub-study 7:
- Participants who discontinued prior treatment with pomalidomide due to intolerable adverse events

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126200
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, Georgia | |
GSK Investigational Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Ajay Nooka | |
United States, Indiana | |
GSK Investigational Site | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Attaya Suvannasankha | |
United States, Massachusetts | |
GSK Investigational Site | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Paul Richardson | |
United States, Michigan | |
GSK Investigational Site | Recruiting |
Grand Rapids, Michigan, United States, 49546 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Nehal Lakhani | |
United States, Texas | |
GSK Investigational Site | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Matthew Butler | |
United States, Wisconsin | |
GSK Investigational Site | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Natalie Callander | |
Australia, Victoria | |
GSK Investigational Site | Recruiting |
Fitzroy, Victoria, Australia, 3065 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Hang Quach | |
GSK Investigational Site | Completed |
Melbourne, Victoria, Australia, 3000 | |
Canada, British Columbia | |
GSK Investigational Site | Recruiting |
Vancouver, British Columbia, Canada, V5Z1M9 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kevin Song | |
Canada, Nova Scotia | |
GSK Investigational Site | Recruiting |
Halifax, Nova Scotia, Canada, B3K 1V7 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Darrell White | |
Canada, Ontario | |
GSK Investigational Site | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Suzanne Trudel | |
France | |
GSK Investigational Site | Recruiting |
Lille Cedex, France, 59037 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Thierry Facon | |
GSK Investigational Site | Recruiting |
Mont-de-Marsan, France, 40000 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Reza Tabrizi | |
GSK Investigational Site | Recruiting |
Villejuif Cedex, France, 94805 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Vincent Ribrag | |
Germany | |
GSK Investigational Site | Recruiting |
Frankfurt am Main, Hessen, Germany, 60590 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Ivana von Metzler | |
GSK Investigational Site | Recruiting |
Leipzig, Sachsen, Germany, 04103 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Song-Yau Wang | |
GSK Investigational Site | Recruiting |
Kiel, Schleswig-Holstein, Germany, 24105 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Natalie Schub | |
GSK Investigational Site | Recruiting |
Hamburg, Germany, 20246 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Katja Weisel | |
Greece | |
GSK Investigational Site | Recruiting |
Athens, Greece, 11528 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Meletios Athanasios Dimopoulos | |
Korea, Republic of | |
GSK Investigational Site | Recruiting |
Incheon, Korea, Republic of, 21565 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jae Hoon Lee | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: JaMin Byun | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 06351 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kihyun Kim | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Chang Ki Min | |
GSK Investigational Site | Recruiting |
Ulsan, Korea, Republic of, 44033 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jae-Cheol Jo | |
Mexico | |
GSK Investigational Site | Recruiting |
Mexico City, Mexico, 01330 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jorge Carlos Torres-Flores | |
Netherlands | |
GSK Investigational Site | Recruiting |
Dordrecht, Netherlands, 3318 AT | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Mark-David Levin | |
GSK Investigational Site | Recruiting |
Leeuwarden, Netherlands, 8934 AD | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Esther G.M. de Waal | |
GSK Investigational Site | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Monique C. Minnema | |
Norway | |
GSK Investigational Site | Recruiting |
Oslo, Norway, 0450 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Fredrik Schjesvold | |
Poland | |
GSK Investigational Site | Recruiting |
Gdansk, Poland, 80-214 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Agata Tyczynska | |
GSK Investigational Site | Recruiting |
Katowice, Poland, 40-519 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Sebastian Grosicki | |
GSK Investigational Site | Recruiting |
Lodz, Poland, 93-513 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Pawel Robak | |
GSK Investigational Site | Recruiting |
Lublin, Poland, 20-081 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Marek Hus | |
Russian Federation | |
GSK Investigational Site | Recruiting |
Moscow, Russian Federation, 125284 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Vera A. Zherebtsova | |
GSK Investigational Site | Recruiting |
St'Petersburg, Russian Federation, 191024 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Sergey Voloshin | |
Spain | |
GSK Investigational Site | Recruiting |
Badalona, Spain, 08916 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Albert Oriol Rocafiguera | |
GSK Investigational Site | Recruiting |
Madrid, Spain, 28027 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Paula Rodriguez Otero | |
GSK Investigational Site | Recruiting |
Madrid, Spain, 28040 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Daniel Morillo Giles | |
GSK Investigational Site | Recruiting |
Madrid, Spain, 28041 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Joaquín Martínez López | |
GSK Investigational Site | Recruiting |
Pamplona, Spain, 31008 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Paula Rodriguez Otero | |
GSK Investigational Site | Recruiting |
Pozuelo (Madrid), Spain, 28223 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Aránzazu Alonso Alonso | |
Sweden | |
GSK Investigational Site | Recruiting |
Falun, Sweden, SE-791 82 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Max Flogegård | |
GSK Investigational Site | Recruiting |
Stockholm, Sweden, SE-141 86 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Katarina Uttervall |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT04126200 |
Other Study ID Numbers: |
208887 |
First Posted: | October 15, 2019 Key Record Dates |
Last Update Posted: | September 26, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study. |
Access Criteria: | Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months. |
URL: | http://clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Belantamab mafodotin GSK2857916 GSK3174998 Feladilimab Nirogacestat Dostarlimab |
Isatuximab Lenalidomide Dexamethasone Pomalidomide Platform study Relapsed/Refractory Multiple Myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Lenalidomide Pomalidomide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors |