A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)

May 30, 2026 updated by: GlaxoSmithKline

A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)

This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.

The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

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

  • Germany
      • Koblenz, Germany, 56068
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Guenther
  • 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:
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hiroshi Handa
        • Contact:
        • Contact:
      • Numakunai, Japan, 028-3695
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigeki Ito
        • Contact:
        • Contact:
      • Okayama, Japan, 701-1192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazutaka Sunami
      • Osaka, Japan, 590-0197
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinya Rai
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josien Regelink
  • Spain
      • Madrid, Spain
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arancha Alonso
        • Contact:
        • Contact:
      • Salamanca, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Victoria Mateos Manteca
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nihal Abdulla
      • Torrance, California, United States, 90505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Swati Sikaria
      • Whittier, California, United States, 90602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian Cheng
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shivtaj Mann
    • Georgia
      • Macon, Georgia, United States, 31210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bradley Sumrall
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Victor Priego
        • Contact:
        • Contact:
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • V. Roger Holden
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ankit Anand

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participants are eligible to be included in the study only if all of the following criteria apply:

Applicable to All Arms - BPd, BVd, BKd:

  • Male or female, 18 years or older (at the time consent is obtained).
  • Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.
  • Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.

  • Must have at least 1 aspect of measurable disease, defined as one the following:

    1. Urine M-protein excretion ≥200 mg/24 h, or
    2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
    3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65) only if patient has no measurable urine or serum M spike.

  • Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:

    1. ASCT was >100 days prior to the first dose of study medication,
    2. No active bacterial, viral, or fungal infection(s) present.
  • All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.
  • Adequate organ system functions as defined by the laboratory assessments.
  • Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.
  • Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.

Specific Inclusion Criteria for BPd arm:

• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Applicable for all (BPd, BVd, BKd):

  • Active plasma cell leukemia at Screening.
  • Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).

  • Previous or concurrent invasive malignancy other than MM, except:

    1. The disease must be considered medically stable for at least 2 years; or
    2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Plasmapheresis within 7 days prior to the first dose of study intervention.
  • Patients after prior allogeneic stem cell transplant
  • Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.
  • Evidence of active mucosal or internal bleeding.
  • Intolerance or contraindications to anti-viral prophylaxis.
  • Current corneal epithelial disease except for mild punctate keratopathy.
  • Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.
  • Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria
  • Received prior B-cell maturation antigen (BCMA)-targeted therapy.
  • Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.
  • HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.
  • Significant liver dysfunction (ALT >2.5x ULN, bilirubin >1.5x ULN, cirrhosis, unstable liver/biliary disease).
  • Positive hepatitis B or C markers unless criteria for resolved infection are met.
  • Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI/ACS/angioplasty/bypass, NYHA III/IV heart failure, uncontrolled hypertension, QTc prolongation.

Specific Exclusion Criteria for BPd Arm:

  • Received prior treatment with or intolerant to pomalidomide.
  • Active or history of venous and arterial thromboembolism within the past 3 months.

Specific Exclusion Criteria for BVd Arm:

  • Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m² twice weekly or within 60 days of completing that treatment).
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.

Specific Exclusion Criteria for BKd Arm:

  • Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).
  • Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.
  • Left ventricular ejection fraction <40% as assessed by transthoracic echocardiogram.
  • Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.
  • Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
  • Known pulmonary hypertension.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Pomalidomide
Pomalidomide will be administered.
Other Names:
  • Imnovid
Experimental: Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Bortezomib
Bortezomib will be administered.
Other Names:
  • Velcade
Experimental: Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Carfilzomib
Carfilzomib will be administered.
Other Names:
  • Kyprolis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to approximately 52 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]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
Up to approximately 52 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: Up to approximately 52 months
CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).
Up to approximately 52 months
Minimal Residual Disease (MRD) Negativity Rate
Time Frame: Up to approximately 52 months
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status (as assessed by Next generation sequencing [NGS] at 10^-5 threshold) at least once during the time of confirmed CR or better response as per IMWG.
Up to approximately 52 months
Duration of Response (DoR)
Time Frame: Up to approximately 52 months
DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.
Up to approximately 52 months
Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Number of Participants With Ocular Findings on Ophthalmic Examination by severity
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings
Time Frame: Up to approximately 52 months
Ophthalmic examination findings will be summarized, and contingency table will be constructed to assess the concordance between the results from patient questionnaires (Ocular Surface Disease Index [OSDI], PRO-CTCAE ocular scale, and PROSIM-Q) and findings from clinician assessments (CTCAE for eye disorders and Keratopathy and Visual Acuity [KVA] grading scale). The proportion of participants showing concordance will be calculated from this analysis.
Up to approximately 52 months

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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)

April 15, 2026

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2030

Study Registration Dates

First Submitted

November 10, 2025

First Submitted That Met QC Criteria

November 10, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224317
  • 2025-523117-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor 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/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 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

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.

Clinical Trials on Multiple Myeloma

Clinical Trials on Belantamab mafodotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe