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Bortezomib, Lenalidomide and Dexamethasone (VRd) With Belantamab Mafodotin Versus VRd Alone in Transplant Ineligible Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04091126
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with VRd compared with VRd alone in adult participants with transplant ineligible (TI) newly diagnosed multiple myeloma (NDMM). The study will consist of 2 parts: part 1 will evaluate the safety and tolerability of different doses/dosing regimens of belantamab mafodotin in combination with VRd in an escalating manner and will determine the recommended phase 3 dose (RP3D). Part 2 will evaluate the efficacy and safety of the selected RP3D of belantamab mafodotin in combination with VRd compared with VRd alone.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study consists of two parts. The dose selection part (Part 1) will evaluate the safety and tolerability of escalating doses of belantamab mafodotin in combination with VRd in up to 5 cohorts and will determine the RP3D of belantamab mafodotin in combination with VRd. The randomized Phase 3 part (Part 2) of the study will evaluate the efficacy and safety of the RP3D of belantamab mafodotin plus VRd compared with VRd alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study of Belantamab Mafodotin Administered in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone Alone in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation
Estimated Study Start Date : December 18, 2019
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2029


Arm Intervention/treatment
Experimental: Part 1: Belantamab Mafodotin + VRd/Rd (Cohort 1)
Participants will receive 1.9 milligram (mg)/kilogram (kg) single dose of belantamab mafodotin intravenously (IV) on Day 1 every 21-day cycle for the first 8 (induction) cycle in combination with VRd, and cycle 9 (28-day maintenance cycle) onward in combination with Rd (Revlimid [lenalidomide], dexamethasone).
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 1: Belantamab Mafodotin + VRd/Rd (Cohort 2a)
Participants will receive belantamab mafodotin 1.25 mg/kg on Day 1 and Day 8 through IV of every 21-day cycle for the first 8 (induction) cycles in combination with VRd, and cycle 9 (28-day maintenance cycle) onward in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 1: Belantamab Mafodotin + VRd/Rd (Cohort 2b)
Participants will receive 2.5 mg/kg on single dose of belantamab mafodotin through IV on Day 1, every 21-day cycle for the first 8 (induction) cycles in combination with VRd, and cycle 9 (28-day maintenance cycle) onward in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 1: Belantamab Mafodotin + VRd/Rd (Cohort 3)
Participants will receive belantamab mafodotin 1.7 mg/kg on Day 1 and Day 8 through IV, every 21-day cycle for the first 8 (induction) cycles in combination with VRd, and cycle 9 (28-day maintenance cycle) onward in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 1: Belantamab Mafodotin + VRd/Rd (Cohort 4)
Participants will receive 3.4 mg/kg single dose of belantamab mafodotin through IV on Day 1, every 21-day cycle for the first 8 (induction) cycles in combination with VRd, and cycle 9 (28-day maintenance cycle) onward in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 2: Belantamab Mafodotin + VRd
Participants will receive selected dose of belantamab mafodotin RP3D plus VRd (1.3 milligrams per square meter [mg/m^2] of bortezomib subcutaneously [SC] on Days 1, 4, 8, and 11, lenalidomide 25 mg on Days 1-14, and dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 orally) of every 21-day cycle for the 8 induction cycles, and with Rd (lenalidomide 25 mg on Days 1-21 and dexamethasone 40 mg on Days 1, 8, 15, 22) of each 28-day cycle until PD (progressive disease) or unacceptable toxicity.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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: Part 2: VRd alone
Participants will receive VRd (1.3 mg/m^2 of bortezomib SC on Days 1, 4, 8, and 11, lenalidomide 25 mg on Days 1-14, and dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 orally) of every 21-day cycle for the 8 induction cycles, and with Rd (lenalidomide 25 mg on Days 1-21 and dexamethasone on 40 mg on Days 1, 8, 15, 22) of each 28-day cycle until PD or unacceptable toxicity
Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

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.




Primary Outcome Measures :
  1. Part 1: Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: 1 cycle of treatment (21 days) ]
    An event is considered to be a DLT if the event occurs within the first 21 days of treatment and meets the DLT criteria. Number of participants with DLTs will be reported.

  2. Part 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Approximately 12 Weeks ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is congenital anomaly/birth defect, and, other situations which involve medical or scientific judgment.

  3. Part 2: Percentage of participants with negative minimal residual disease (MRD [ Time Frame: Up to 12 months ]
    MRD negativity rate is defined as the percentage of participants who are MRD negative by next-generation sequencing (NGS) with a level of 10^5.

  4. Part 2: Progression-free survival (PFS) [ Time Frame: Up to an average of 44 months ]
    PFS is defined the time from the date of randomization until the earliest date of documented disease progression or death due to any cause.


Secondary Outcome Measures :
  1. Part 1: Lenalidomide relative dose intensity (RDI ) of treatment with belantamab mafodotin in combination with VRd [ Time Frame: Approximately 12 Weeks ]
    RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

  2. Part 1: Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd [ Time Frame: Approximately 12 Weeks ]
    RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

  3. Part 1: Cumulative administered dose of belantamab mafodotin treatment in combination with VRd [ Time Frame: Approximately 12 Weeks ]
    Cumulative administered dose of belantamab mafodot in treatment in combination with VRd will be analyzed.

  4. Part 1: Maximum plasma concentration (Cmax) of belantamab mafodotin [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  5. Part 1:Cmax of total monoclonal antibody (mAb) [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  6. Part1: Cmax of microtubule inhibitor monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  7. Part 1: Area under the concentration time curve (AUC) of belantamab mafodotin [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  8. Part 1: AUC of monoclonal antibody (mAb) [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  9. Part1: AUC of cys-mcMMAF [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  10. Part1: Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to an average of 44 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.

  11. Part1: Titers of ADAs against belantamab mafodotin [ Time Frame: Up to an average of 44 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.

  12. Part 2: Overall Response Rate (ORR) [ Time Frame: From study start for the duration of disease follow-up, for an average of 24 months ]
    ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR], stringent complete response [sCR]).

  13. Part 2: Complete Response Rate (CRR) [ Time Frame: From study start for the duration of disease follow-up, for an average of 24 months ]
    CRR is defined as the percentage of participants with a confirmed CR or better (i.e, CR, sCR).

  14. Part 2: Rate of VGPR or better [ Time Frame: From study start for the duration of disease follow-up, for an average of 24 months ]
    Rate of VGPR or better is defined as the percentage of participants with a confirmed VGPR or better (i.e. VGPR, CR, sCR).

  15. Part 2: Duration of Response (DoR) [ Time Frame: From study start for the duration of disease follow-up, for an average of 24 months ]
    DoR is defined as the time from first documented evidence of PR or better until PD or death due to PD among participants who achieve confirmed PR or better.

  16. Part 2: Time to progression (TTP) [ Time Frame: From study start for the duration of disease follow-up, for an average of 24 months ]
    TTP is defined as the time from the date of randomization until the earliest date of documented PD or death due to PD

  17. Part 2: Overall Survival (OS) [ Time Frame: Up to 60 months ]
    OS is defined as the time from the date of randomization until the date of death due to any cause

  18. Part 2: Percentage of participants with Sustained MRD negativity [ Time Frame: 1 year ]
    Sustained MRD negativity defined as the percentage of participants with MRD negativity confirmed 1 year apart.

  19. Part 2: Number of participants with AEs and SAEs [ Time Frame: Up to an average of 44 months ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is congenital anomaly/birth defect, and, other situations which involve medical or scientific judgment.

  20. Part 2: Number of participants with abnormal ocular findings [ Time Frame: Up to an average of 44 months ]
    A full ophthalmic examination for all participants will be conducted for any abnormal ocular findings.

  21. Part 2: Plasma concentrations of belantamab mafodotin [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points to analyze the plasma concentration.

  22. Part 2: Plasma concentrations of total mAb [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points to analyze the plasma concentration.

  23. Part 2: Plasma concentrations of cys-mcMMAF [ Time Frame: Up to an average of 44 months ]
    Blood samples will be collected at indicated time points to analyze the plasma concentration.

  24. Part 2: Number of participants with ADAs against belantamab mafodotin [ Time Frame: Up to an average of 44 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.

  25. Part 2: Titers of ADAs against belantamab mafodotin [ Time Frame: Up to an average of 44 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

  26. Part 2: Change from Baseline in Health-related quality of life (HRQOL) as measured by European Organization for Research and Treatment of Cancer Quality of life questionnaire (EORTC QLQ)-C30 [ Time Frame: Baseline and up to an average of 44 months ]
    EORTC QLQ-C30 is a 30-item questionnaire containing both single- and multi-item measures. These include 5 functional scales (physical, role, cognitive, emotional, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (constipation, diarrhea, insomnia, dyspnea, appetite loss, and financial difficulties). Scores for each scale and single-item measure are averaged and transformed linearly to a score ranging from 0-100. A high score for functional scales and for Global Health Status/QoL represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.

  27. Part 2: Change from Baseline in HRQOL as measured by EORTC QLQ-MY20 [ Time Frame: Baseline and up to an average of 44 months ]
    EORTC QLQ-MY20 symptoms (pain) domain is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. Only the Disease Symptoms domain of the QLQ-MY20 will be administered, which includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. As with the QLQ-C30, QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. Higher score represents a high level of symptomatology or problems.

  28. Part 2: Changes from Baseline in participants-reported outcome common terminology criteria for adverse events (PRO-CTCAE) score [ Time Frame: Baseline and up to an average of 44 months ]
    The PRO-CTCAE includes an item library of 124 items representing 80 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE provides a systematic yet flexible tool for descriptive reporting of symptomatic treatment side effects in cancer clinical trials. In the present study, a subset of items selected from the PRO-CTCAE Version 1.0 Item Library will be administered. The symptoms and related impacts will be assessed using PRO-CTCAE score.

  29. Part 2: Changes from Baseline in ocular surface disease index (OSDI) [ Time Frame: Baseline and up to an average of 44 months ]
    The impact of potential ocular toxicity on function and health-related quality of life will be assessed with the use of the visual function questionnaire the OSDI. OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The OSDI has demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a complement to other clinical and participative measures of dry eye disease by providing a quantifiable assessment of dry eye symptom frequency and the impact of these symptoms on vision-related functioning. The symptoms and related impacts will be assessed using OSDI score.



Information from the National Library of Medicine

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.


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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.
  • 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 (hrs) (>=0.2 gram [g]/24 hrs), 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 frailty and/or 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
  • Male and/or female
  • 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 WOCBP participants must use a contraceptive method that is highly effective as detailed in the protocol.
  • Male participants are eligible to participate if they agree to the following:
  • Refrain from donating sperm
  • Plus either:
  • Be abstinent from heterosexual intercourse or must use a contraceptive method that is highly effective as detailed in the protocol.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Smoldering multiple myeloma (SMM).
  • Prior systemic therapy for multiple myeloma, or SMM. 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.
  • Patient is eligible for high dose chemotherapy with ASCT.
  • 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.
  • Evidence of cardiovascular risk.
  • 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. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
  • 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.
  • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.

Information from the National Library of Medicine

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): NCT04091126


Contacts
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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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04091126     History of Changes
Other Study ID Numbers: 209664
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
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 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Bortezomib, lenalidomide and dexamethasone
Belantamab mafodotin
Dose escalation
Newly diagnosed multiple myeloma
Additional relevant MeSH terms:
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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
Dexamethasone acetate
Lenalidomide
Bortezomib
BB 1101
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