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Multiple MyelomaPhase 1/2DREAMM 5NCT04126200

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

A Phase 1/2 study testing Belantamab mafodotin, GSK3174998 and Feladilimab in people with Multiple Myeloma, run by GlaxoSmithKline at 38 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Belantamab mafodotin, GSK3174998 and Feladilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
38 sitesin 13 countries
Study dates
7 Oct 2019to 11 Mar 2027
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

38 sites in 13 countries.

38 sites in 13 countries

Spain6 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Madrid, 28027

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    PamplonaNavarra, 31008

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223

Other trials in Spain

United States5 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Grand Rapids, Michigan, 49546

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Madison, Wisconsin, 53792

Other trials in United States

Germany4 sites

  • GSK Investigational Site

    Frankfurt, 60590

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Kiel, 24105

  • GSK Investigational Site

    Leipzig, 04103

Other trials in Germany

Poland4 sites

  • GSK Investigational Site

    Gdansk, 80-214

  • GSK Investigational Site

    Katowice, 40-519

  • GSK Investigational Site

    Lodz, 93-513

  • GSK Investigational Site

    Lublin, 20-081

Other trials in Poland

South Korea4 sites

  • GSK Investigational Site

    Incheon, 21565

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 06351

  • GSK Investigational Site

    Seoul, 06591

Other trials in South Korea

Brazil3 sites

  • GSK Investigational Site

    Porto Alegre, 90110-270

  • GSK Investigational Site

    Salvador, 41253-190

  • GSK Investigational Site

    São Paulo, 04537-080

Other trials in Brazil

Canada3 sites

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z1M9

Other trials in Canada

France2 sites

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Netherlands2 sites

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Sweden2 sites

  • GSK Investigational Site

    Falun, SE-791 82

  • GSK Investigational Site

    Stockholm, SE-141 86

Other trials in Sweden

Greece1 site

  • GSK Investigational Site

    Athens, 11528

Other trials in Greece

Mexico1 site

  • GSK Investigational Site

    Mexico City, 01330

Other trials in Mexico

Norway1 site

  • GSK Investigational Site

    Oslo, 0450

Other trials in Norway

About this study

Official title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5

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.

Being tested
Belantamab mafodotin, GSK3174998, Feladilimab, Nirogacestat, Dostarlimab
Keywords
Belantamab mafodotin, GSK2857916, GSK3174998, Feladilimab, Nirogacestat, Dostarlimab, Isatuximab, Lenalidomide, Dexamethasone, Pomalidomide, Platform study, Relapsed/Refractory Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotinDrug

    Belantamab mafodotin will be administered.

  • GSK3174998Drug

    GSK3174998 will be administered.

  • FeladilimabDrug

    feladilimab will be administered.

  • NirogacestatDrug

    Nirogacestat will be administered.

  • DostarlimabDrug

    Dostarlimab will be administered.

  • IsatuximabDrug

    Isatuximab will be administered.

  • LenalidomideDrug

    Lenalidomide will be administered.

  • DexamethasoneDrug

    Dexamethasone will be administered.

  • PomalidomideDrug

    Pomalidomide will be administered.

Study groups in NCT04126200
Study groupRoleWhat they receive
Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: GSK3174998
Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Feladilimab
Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat
Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Dostarlimab
Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Isatuximab
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat; Drug: Lenalidomide; Drug: Dexamethasone
Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat; Drug: Dexamethasone; Drug: Pomalidomide
Belantamab mafodotin monotherapy cohort expansionActive comparatorNot described
Receives: Drug: Belantamab mafodotin
Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: GSK3174998
Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Feladilimab
Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat
Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Dostarlimab
Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Isatuximab
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat; Drug: Lenalidomide; Drug: Dexamethasone
Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)ExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Nirogacestat; Drug: Dexamethasone; Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Randomized Across Sub-studies

    Number of Participants who passed screening and were randomized across sub studies are presented.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start7 Oct 2019
  3. Primary completion17 Apr 2025
  4. Study completion11 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
There will be a dose exploration (DE) phase which will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with other anti-cancer treatments. A recommended Phase 2 dose (RP2D) for each combination treatment will be identified based on the safety and preliminary efficacy in DE. This will be followed by a cohort expansion (CE) phase which will evaluate the clinical activity of the combination treatment in comparison to belantamab mafodotin monotherapy in additional participants.
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126200
Sponsor's protocol ID
208887
Other IDs
2023-509550-55-00, 2023
Acronym
DREAMM 5
Status last verified
Apr 2026
First submitted
11 Oct 2019
Last updated
6 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.
Expanded access
Available

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.

    PubMed 33730360

  • 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.

    PubMed 33682447

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Belantamab mafodotin, GSK3174998 and Feladilimab in people with Multiple Myeloma, run by GlaxoSmithKline at 38 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Spain, United States, Germany, Poland, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Randomized Across Sub-studies (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126200, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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