Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5)

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

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Belantamab mafodotin; Drug: Feladilimab; Drug: Dostarlimab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: GSK3174998; Drug: Nirogacestat; Drug: Isatuximab; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2; Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil, 90110-270
    • GSK Investigational Site
  • Salvador, Brazil, 41253-190
    • GSK Investigational Site
  • São Paulo, Brazil, 04537-080
    • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
• France
  • Lille, France, 59037
    • GSK Investigational Site
  • Villejuif, France, 94805
    • GSK Investigational Site
• Germany
  • Frankfurt, Germany, 60590
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Kiel, Germany, 24105
    • GSK Investigational Site
  • Leipzig, Germany, 04103
    • GSK Investigational Site
• Greece
  • Athens, Greece, 11528
    • GSK Investigational Site
• Mexico
  • Mexico City, Mexico, 01330
    • GSK Investigational Site
• Netherlands
  • Leeuwarden, Netherlands, 8934 AD
    • GSK Investigational Site
  • Utrecht, Netherlands, 3584 CX
    • GSK Investigational Site
• Norway
  • Oslo, Norway, 0450
    • GSK Investigational Site
• Poland
  • Gdansk, Poland, 80-214
    • GSK Investigational Site
  • Katowice, Poland, 40-519
    • GSK Investigational Site
  • Lodz, Poland, 93-513
    • GSK Investigational Site
  • Lublin, Poland, 20-081
    • GSK Investigational Site
• South Korea
  • Incheon, South Korea, 21565
    • GSK Investigational Site
  • Seoul, South Korea, 03080
    • GSK Investigational Site
  • Seoul, South Korea, 06351
    • GSK Investigational Site
  • Seoul, South Korea, 06591
    • GSK Investigational Site
• Spain
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28027
    • GSK Investigational Site
  • PamplonaNavarra, Spain, 31008
    • GSK Investigational Site
  • Pozuelo de AlarcOn Madr, Spain, 28223
    • GSK Investigational Site
• Sweden
  • Falun, Sweden, SE-791 82
    • GSK Investigational Site
  • Stockholm, Sweden, SE-141 86
    • GSK Investigational Site
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • GSK Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

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

Description

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 immunomodulating 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 and7:

• 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.
• Participants with Known HIV infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load<400 copies/mL b) CD4+ T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of AIDS-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.

For patients receiving nirogacestat, HIV drugs that are strong CYP3A4 inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications.

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 and 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

15

Arms and Interventions

Participant Group / 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: Dexamethasone; Dexamethasone will be administered.; Drug: Lenalidomide; Lenalidomide will be administered.; Drug: Nirogacestat; Nirogacestat 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: Nirogacestat; Nirogacestat 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: Dexamethasone; Dexamethasone will be administered.; Drug: Lenalidomide; Lenalidomide will be administered.; Drug: Nirogacestat; Nirogacestat 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: Nirogacestat; Nirogacestat will be administered.; Drug: Pomalidomide; Pomalidomide will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Randomized Across Sub-studies	Number of Participants who passed screening and were randomized across sub studies are presented.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DE Phase: Number of participants achieving ORR	ORR is defined as the percentage of participants with PR or better, according to the IMWG Response Criteria.	Up to 12 months
DE Phase: Number of participants achieving Partial Response (PR)	Number of participants with PR according to IMWG criteria will be analyzed.	Up to 12 months
CE Phase: Number of participants achieving PR	Number of participants with PR according to IMWG criteria will be analyzed.	Up to 36 months
DE Phase: Number of participants achieving Very Good Partial Response (VGPR)	Number of participants with VGPR according to IMWG criteria will be analyzed.	Up to 12 months
CE Phase: Number of participants achieving VGPR	Number of participants with VGPR according to IMWG criteria will be analyzed.	Up to 36 months
DE Phase: Number of participants achieving Complete Response (CR)	Participants with CR according to IMWG criteria will be analyzed.	Up to 12 months
CE Phase: Number of participants achieving CR	Participants with CR according to IMWG criteria will be analyzed.	Up to 36 months
DE Phase: Number of participants achieving stringent Complete Response (sCR)	Participants with sCR according to IMWG criteria will be analyzed.	Up to 12 months
CE Phase: Number of participants achieving sCR	Participants with sCR according to IMWG criteria will be analyzed.	Up to 36 months
DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments	Blood samples will be collected for concentrations of belantamab mafodotin.	Up to 12 months
CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments	Blood samples will be collected for concentrations of belantamab mafodotin.	Up to 36 months
DE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of GSK3174998.	Up to 12 months
CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of GSK3174998.	Up to 36 months
DE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of feladilimab.	Up to 12 months
CE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of feladilimab.	Up to 36 months
DE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of nirogacestat.	Up to 12 months
CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of nirogacestat.	Up to 36 months
DE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of dostarlimab.	Up to 12 months
CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of dostarlimab.	Up to 36 months
DE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of isatuximab.	Up to 12 months
CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin	Blood samples will be collected for concentrations of isatuximab.	Up to 36 months
DE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments	Blood samples for concentrations for ADAs will be collected.	Up to 12 months
CE Phase: Concentration of ADAs against belantamab mafodotin when administered in combination with anti-cancer treatments	Blood samples for concentrations for ADAs will be collected.	Up to 36 months
DE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 12 months
CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 36 months
DE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 12 months
CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 36 months
DE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 12 months
CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 36 months
DE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 12 months
CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin	Blood samples for concentrations for ADAs will be collected.	Up to 36 months
DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for belantamab mafodotin	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with AESI for GSK3174998	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for GSK3174998	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with AESI for Feladilimab	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for Feladilimab	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with AESI for Nirogacestat	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for Nirogacestat	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with AESI for Dostarlimab	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for Dostarlimab	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with AESI for Isatuximab	AESIs will be collected.	Up to 12 months
CE Phase: Number of participants with AESI for Isatuximab	AESIs will be collected.	Up to 36 months
DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination	Ophthalmic examination will assess abnormal findings.	Up to 12 months
CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination	Ophthalmic examination will assess abnormal findings.	Up to 36 months
CE Phase: Number of participants achieving Progression-free survival (PFS)	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.	Up to 36 months
CE Phase: Duration of response (DoR)	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.	Up to 36 months
CE Phase: Time to response (TTR)	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).	Up to 36 months
CE Phase: Number of participants achieving Overall survival (OS)	OS is defined as the time from randomization until death due to any cause.	Up to 36 months
CE Phase: Number of participants with AEs and SAEs	AEs and SAEs will be collected.	Up to 36 months
CE Phase: Number of participants with AEs leading to discontinuation	Number of participants with AEs leading to discontinuation will be evaluated.	Up to 36 months
CE Phase: Number of participants with dose reduction or delay	Number of participants with dose reduction or delay will be evaluated.	Up to 36 months
CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters	Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.	Up to 36 months
CE Phase: Number of participants achieving Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with a minimal response (MR) or better, according to IMWG response criteria.	Up to 36 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17.
• Nooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): April 17, 2025
• Study Completion (Estimated): March 11, 2027

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pomalidomide; Lenalidomide; Dexamethasone; Relapsed/Refractory Multiple Myeloma; Nirogacestat; Isatuximab; Platform study; Belantamab mafodotin; Dostarlimab; GSK2857916; GSK3174998; Feladilimab
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Dexamethasone; pomalidomide; belantamab mafodotin; isatuximab; nirogacestat; dostarlimab
• Other Study ID Numbers: 208887; 2023-509550-55-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No