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)

NCT07227311 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2243172025-523117-28-00
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

Relapsed-Refractory Multiple Myeloma; DREAMM-15; Belantamab Mafodotin; Blenrep; Pomalidomide; Bortezomib; Carfilzomib; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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 Outcomes (7)

• Complete Response Rate (CRR)

  Up to approximately 52 months

• Minimal Residual Disease (MRD) Negativity Rate

  Up to approximately 52 months

• Duration of Response (DoR)

  Up to approximately 52 months

• Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity

  Up to approximately 52 months

• Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation

  Up to approximately 52 months

Study Arms (3)

Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Pomalidomide

Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib

Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Carfilzomib

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin will be administered.

Also known as: Blenrep

Belantamab mafodotin + Bortezomib + Dexamethasone (BVd); Belantamab mafodotin + Carfilzomib + dexamethasone (BKd); Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)

Dexamethasone DRUG

Dexamethasone will be administered.

Belantamab mafodotin + Bortezomib + Dexamethasone (BVd); Belantamab mafodotin + Carfilzomib + dexamethasone (BKd); Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)

Pomalidomide DRUG

Pomalidomide will be administered.

Also known as: Imnovid

Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)

Bortezomib DRUG

Bortezomib will be administered.

Also known as: Velcade

Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)

Carfilzomib DRUG

Carfilzomib will be administered.

Also known as: Kyprolis

Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Urine M-protein excretion ≥200 mg/24 h, or
• Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
• 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:
• ASCT was \>100 days prior to the first dose of study medication,
• 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.

You may not qualify if:

• 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:
• The disease must be considered medically stable for at least 2 years; or
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Fort Myers, Florida, 33912, United States

RECRUITING

GSK Investigational Site

Macon, Georgia, 31210, United States

RECRUITING

GSK Investigational Site

Bethesda, Maryland, 20817, United States

RECRUITING

GSK Investigational Site

Springfield, Missouri, 65807, United States

RECRUITING

GSK Investigational Site

Farmington, New Mexico, 87401, United States

RECRUITING

GSK Investigational Site

Ehime, 790-8524, Japan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; Dexamethasone; pomalidomide; Bortezomib; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 12, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

JP (1); US (5)