Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma (DREAMM 9)

• ClinicalTrials.gov Identifier: NCT04091126
• Recruitment Status: Recruiting
• First Posted: September 16, 2019
• Last Update Posted: July 25, 2022
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone	Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: The study will evaluate different doses/dose schedules of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone, (VRd) in up to 8 cohorts and will determine the Recommended Phase 3 dose (RP3D).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma
• Actual Study Start Date: December 18, 2019
• Estimated Primary Completion Date: April 18, 2025
• Estimated Study Completion Date: November 3, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd; Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd; Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd; Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd; Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd; Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd; Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd; Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd; Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd; Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd; Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Drug: Belantamab mafodotin; Selected doses of belantamab mafodotin will be administered as intravenous infusion.; Drug: Bortezomib; Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.; Drug: Lenalidomide; Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.; Drug: Dexamethasone; Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Outcome Measures

Primary Outcome Measures :

1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Treatment cycle 1 to 3 (each cycle of 21 days) ]
   The number of participants with DLTs will be reported.
2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to an average of 54 months ]
   AEs and SAEs will be collected.

Secondary Outcome Measures :

1. Lenalidomide relative dose intensity (RDI ) of treatment with belantamab mafodotin in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
   RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.
2. Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
   RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.
3. Cumulative administered dose of belantamab mafodotin treatment in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
   Cumulative administered dose of belantamab mafodotin in treatment in combination with VRd will be analyzed.
4. Maximum plasma concentration (Cmax) of belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
   Blood samples will be collected at indicated time points for pharmacokinetic analysis.
5. Cmax of microtubule inhibitor monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) [ Time Frame: Up to an average of 52 months ]
   Blood samples will be collected at indicated time points for pharmacokinetic analysis.
6. Area under the concentration time curve (AUC) of belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
   Blood samples will be collected at indicated time points for pharmacokinetic analysis.
7. AUC of cys-mcMMAF [ Time Frame: Up to an average of 52 months ]
   Blood samples will be collected at indicated time points for pharmacokinetic analysis.
8. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
   Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.
9. Titers of ADAs against belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
   Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.
10. Overall Response Rate (ORR) [ Time Frame: Up to 52 months ]
    ORR is defined as the percentage of participants with a confirmed partial response (PR) or better based on the response assessed by the investigator using International Myeloma Working Group (IMWG) criteria.
11. Complete Response Rate (CRR) [ Time Frame: Up to 52 months ]
    CRR is defined as the percentage of participants with a confirmed complete response (CR) or better based on the response assessed by the investigator using IMWG criteria.
12. Rate of Very Good Partial Response (VGPR) or better [ Time Frame: Up to 52 months ]
    Rate of VGPR or better is defined as the percentage of participants with a confirmed VGPR or better based on the response assessed by the investigator using IMWG criteria.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
• Diagnosis of multiple myeloma with a requirement for treatment as documented per international myeloma working group (IMWG) criteria.
• Must have at least one aspect of measurable disease, defined as one of the following:
• Urine M-protein excretion >=200 mg/24 hours (>=0.2 gram [g]/24 hours), or
• Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 gram per liter [g/L]), or
• Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
• Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to presence of significant comorbid condition(s), such as cardiac, pulmonary or other major organ dysfunction that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation, as judged by the investigator.
• Eastern cooperative oncology group (ECOG) status of 0-2
• Adequate organ system functions as defined by the laboratory assessments listed as following: Absolute neutrophil count (ANC) >=1.5 x 10^9/L; Hemoglobin >=8.0 g/dL; Platelets >=75 x 10^9/L; Total bilirubin <=1.5 x upper limit of normal (ULN); (Isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%); Alanine aminotransferase (ALT) <=2.5 x ULN; eGFR >=30 mL/minute/1.73 meter^2; Urine Dipstick for protein OR Albumin/creatinine ratio (from spot urine)- Negative/trace (if >=1 plus only eligible if confirmed <=500 mg/gram (56 mg/millimoles [mmol]) by albumin/creatinine ratio (spot urine from first void); Left Ventricular Ejection Fraction (LVEF) by echocardiogram (ECHO) of >=35% participants with low LVEF (per institutional standards), consider referring to cardiology per local standards of care.
• Sex and Contraception/Barrier Requirements (Female):
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• Is NOT a woman of childbearing potential (WOCBP) or Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, and bortezomib having the potential to cause fetal harm, WOCBP participants will be eligible if they commit to either: abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR to use birth control as follows: Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use one method of reliable birth control that is highly effective for a further 3 months following discontinuation of belantamab mafodotin, or a further 6 months following discontinuation of bortezomib, whichever is longer. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of lenalidomide, 4 months following discontinuation of belantamab mafodotin treatment or 7-months following the last dose of bortezomib, whichever is longer. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing the start of lenalidomide therapy.

The participant should not receive lenalidomide until the investigator has verified that the results of these pregnancy tests are negative. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

• Sex and Contraception/Barrier Requirements (Male):
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, 4-months after the last dose of bortezomib, or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm: Refrain from donating sperm - Plus either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP. Male participants should also use a condom when having sexual intercourse with pregnant females.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Smoldering multiple myeloma (SMM).
• Prior systemic therapy for multiple myeloma, or SMM. NOTE: An emergency course of steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. NOTE: Focal palliative radiation is permitted prior to enrollment, provided that it occurred at least 2 weeks prior to the first dose of study drug, that the participant has recovered from radiation-related toxicities, and that the participant did not require corticosteroids for radiation-induced adverse events.
• Participant is eligible for high dose chemotherapy with ASCT, as determined by a frailty score of 0 as assessed by the IMWG frailty index.
• Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) Version 5.
• Major surgery within 4 weeks prior to the first dose of study drug.
• Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect participant's safety). Participants with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil criteria.
• Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
• Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
• Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the Investigator's assessment).
• Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
• Evidence of cardiovascular risk including any of following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
• Active infection requiring treatment.
• Known human immunodeficiency virus (HIV) infection.
• Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), at Screening or within 3 months prior to first dose of study treatment.
• Positive hepatitis C antibody test result.
• Current corneal epithelial disease except for mild punctate keratopathy. Note: Participants with mild punctate keratopathy are allowed.
• Intolerance or contraindications to anti-viral prophylaxis.
• Unable to tolerate antithrombotic prophylaxis.
• AL amyloidosis (light chain amyloidosis), active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) syndrome or active plasma cell leukemia at the time of screening.
• Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
• Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
• Plasmapheresis within 7 days prior to the first dose of study drug.

Contacts and Locations

Contacts

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

Locations

United States, Arizona

GSK Investigational Site; Recruiting

Yuma, Arizona, United States, 85364

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: Abhinav Chandra

United States, Kansas

GSK Investigational Site; Recruiting

Westwood, Kansas, United States, 66205

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: Al-Ola Abdallah

United States, North Carolina

GSK Investigational Site; Recruiting

Charlotte, North Carolina, United States, 28204

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: Barry Adam Paul

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, New South Wales

GSK Investigational Site; Recruiting

Waratah, New South Wales, Australia, 2298

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: Wojciech Janowski

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

Canada, Alberta

GSK Investigational Site; Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

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: Irwindeep Sandhu

Canada, Ontario

GSK Investigational Site; Completed

London, Ontario, Canada, N6A 5W9

France

GSK Investigational Site; Recruiting

Poitiers cedex, France, 86021

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: Xavier Leleu

Germany

GSK Investigational Site; Recruiting

Heidelberg, Baden-Wuerttemberg, Germany, 69120

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: Marc Raab

GSK Investigational Site; Recruiting

Tuebingen, Baden-Wuerttemberg, Germany, 72076

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: Britta Besemer

GSK Investigational Site; Completed

Schwerin, Mecklenburg-Vorpommern, Germany, 19049

GSK Investigational Site; Recruiting

Koblenz, Rheinland-Pfalz, Germany, 56068

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Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator: Joerg Thomalla

GSK Investigational Site; Recruiting

Dresden, Sachsen, Germany, 01307

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Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator: Thomas Illmer

GSK Investigational Site; Recruiting

Hamburg, Germany, 20246

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Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator: Katja Weisel

Italy

GSK Investigational Site; Recruiting

Bologna, Emilia-Romagna, Italy, 40138

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Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator: Michele Cavo

GSK Investigational Site; Recruiting

Meldola, Emilia-Romagna, Italy, 47014

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: Claudio Cerchione

GSK Investigational Site; Recruiting

Roma, Lazio, Italy, 00161

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: Maurizio Martelli

Korea, Republic of

GSK Investigational Site; Recruiting

Seoul, Korea, Korea, Republic of, 137-701

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

Seoul, Korea, Republic of, 03080

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Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator: Youngil Koh

GSK Investigational Site; Recruiting

Seoul, Korea, Republic of, 03722

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: Jin Seok Kim

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

Poland

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

GSK Investigational Site; Recruiting

Poznan, Poland, 61-848

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: Dominik Dytfeld

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

Barcelona, Spain, 08036

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: Laura Rosinol Dachs

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

Málaga, Spain, 29010

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: Ricarda García Sánchez

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 De Alarcón/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

GSK Investigational Site; Recruiting

Santander, Spain, 39008

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: Enrique María Ocio San Miguel

United Kingdom

GSK Investigational Site; Completed

Southampton, Hampshire, United Kingdom, SO16 6YD

GSK Investigational Site; Recruiting

Headington, Oxford, United Kingdom, OX3 7LE

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: Karthik Ramasamy

GSK Investigational Site; Recruiting

Leicester, United Kingdom, LE1 5WW

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: Mamta Garg

GSK Investigational Site; Recruiting

London, United Kingdom, SE1 9RT

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: Majid Kazmi

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04091126
• Other Study ID Numbers: 209664
• First Posted: September 16, 2019
• Last Update Posted: July 25, 2022
• Last Verified: July 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

Keywords provided by GlaxoSmithKline:

Bortezomib; Lenalidomide; dexamethasone; VRd; Belantamab mafodotin; Newly diagnosed multiple myeloma; RP3D; DREAMM 9

Additional relevant MeSH terms:

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; Bortezomib; 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