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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

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)

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) is a Phase 2 interventional studying Multiple Myeloma, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: • 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Dexamethasone

Dexamethasone will be administered.

DRUG

Pomalidomide

Pomalidomide will be administered.

DRUG

Bortezomib

Bortezomib will be administered.

DRUG

Carfilzomib

Carfilzomib will be administered.

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Los Alamitos, California, United States
GSK Investigational Site
Torrance, California, United States
GSK Investigational Site
Whittier, California, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Macon, Georgia, United States
GSK Investigational Site
Bethesda, Maryland, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
Farmington, New Mexico, United States
GSK Investigational Site
Koblenz, Germany
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Ehime, Japan
GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Numakunai, Japan
GSK Investigational Site
Okayama, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Amersfoort, Netherlands
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Salamanca, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07227311), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07227311 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07227311?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07227311?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07227311. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07227311. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.