Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM5)

February 23, 2024 updated by: GlaxoSmithKline

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

464

Phase

  • Phase 2
  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hang Quach
        • Contact:
        • Contact:
      • Melbourne, Victoria, Australia, 3000
        • Completed
        • GSK Investigational Site
  • Brazil
      • São Paulo, Brazil, 01236-030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Bellesso
      • São Paulo, Brazil, 04537-080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vania Hungria
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nelson Hamerschlak
    • Bahía
      • Salvador, Bahía, Brazil, 41253-190
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edvan de Queiroz Crusoe
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Capra
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Irwindeep Sandhu
        • Contact:
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kevin Song
        • Contact:
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Darrell White
        • Contact:
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suzanne Trudel
  • France
      • Lille Cedex, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thierry Facon
        • Contact:
        • Contact:
      • Lyon cedex 08, France, 69373
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe Rey
      • Mont-de-Marsan, France, 40000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reza Tabrizi
      • Villejuif Cedex, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vincent Ribrag
        • Contact:
        • Contact:
  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katja Weisel
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ivana von Metzler
        • Contact:
        • Contact:
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Song-Yau Wang
        • Contact:
        • Contact:
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Natalie Schub
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meletios Athanasios Dimopoulos
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Noa Lavi
        • Contact:
        • Contact:
      • Petach Tikva, Israel, 49100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julia Vaxman
        • Contact:
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yael Cohen
  • Japan
      • Aichi, Japan, 467-8602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinsuke Iida
      • Ehime, Japan, 790-8524
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomoaki Fujisaki
        • Contact:
        • Contact:
      • Tokyo, Japan, 150-8935
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadao Ishida
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae Hoon Lee
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chang Ki Min
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Youngil Koh
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kihyun Kim
        • Contact:
        • Contact:
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jae-Cheol Jo
        • Contact:
        • Contact:
  • Mexico
      • Mexico City, Mexico, 01330
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jorge Carlos Torres-Flores
        • Contact:
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Withdrawn
        • GSK Investigational Site
      • Dordrecht, Netherlands, 3318 AT
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mark-David LEVIN
        • Contact:
        • Contact:
      • Enschede, Netherlands, 7512 KZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cleo R. van Rooijen
      • Leeuwarden, Netherlands, 8934 AD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Esther G.M. de Waal
        • Contact:
        • Contact:
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Monique C. Minnema
        • Contact:
        • Contact:
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fredrik Schjesvold
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agata Tyczynska
      • Katowice, Poland, 40-519
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Grosicki
      • Lodz, Poland, 93-513
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pawel Robak
        • Contact:
        • Contact:
      • Lublin, Poland, 20-081
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marek Hus
      • Poznan, Poland, 60-569
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dominik Dytfeld
        • Contact:
        • Contact:
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vladimir Ivanovich Vorobiev
      • St'Petersburg, Russian Federation, 191024
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sergey Voloshin
        • Contact:
        • Contact:
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albert Oriol Rocafiguera
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Morillo Giles
      • Madrid, Spain, 28027
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Rodriguez Otero
        • Contact:
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joaquín Martínez López
        • Contact:
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Rodriguez Otero
        • Contact:
        • Contact:
      • Pozuelo (Madrid), Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Aránzazu Alonso Alonso
        • Contact:
        • Contact:
  • Sweden
      • Falun, Sweden, SE-791 82
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Max Flogegård
        • Contact:
        • Contact:
      • Stockholm, Sweden, SE-141 86
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Katarina Uttervall
        • Contact:
        • Contact:
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ajay Nooka
        • Contact:
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Attaya Suvannasankha
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Richardson
        • Contact:
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nehal Lakhani
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Matthew Butler
        • Contact:
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Natalie Callander
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 milligrams (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 deoxyribonucleic acid (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 6,7, and 8:

  • Participants with contraception requirements specific to Sub-study 6, 7, and 8 respectively.
  • Participants with platelets value for Adequate Organ System Function is ≥75 × 10^9/L.

Inclusion Criteria Specific to Sub-study 8:

- In Japan, participants should reside in Japan and be Japanese as defined by having all biological Japanese grandparents. Similarly, in China, subjects should reside in China and be Chinese as defined by having all biological Chinese grandparents.

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 human immunodeficiency virus (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/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.

For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4 (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 2:

  • Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
  • Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.

Additional Exclusion Criteria for Sub-study 3, 6, 7, and 8:

  • 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, 7, and 8:

  • 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 and 8:

- 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.

Additional Exclusion Criteria for Sub-study 8:

  • Pregnant or lactating female or female who are interrupting lactation.
  • Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)
This cohort will enroll Northeast Asian participants.
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+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)
This cohort will enroll Northeast Asian participants.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 12 months
AEs and SAEs will be collected.
Up to 12 months
DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
Time Frame: Up to 12 months
Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.
Up to 12 months
CE Phase: Number of participants achieving Overall Response Rate (ORR)
Time Frame: Up to 36 months
ORR is defined as the percentage of participants with a Partial response (PR) or better, according to the International Myeloma Working Group (IMWG) Response Criteria.
Up to 36 months
DE Phase: Number of participants achieving dose limiting toxicities (DLT)
Time Frame: Up to 12 months
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets protocol defined DLT criteria.
Up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Estimated)

February 24, 2026

Study Completion (Estimated)

February 12, 2029

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 (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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