Multiple MyelomaPhase 2NCT07227311
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 study testing Belantamab mafodotin, Dexamethasone and Pomalidomide in people with Multiple Myeloma, run by GlaxoSmithKline at 59 sites in 8 countries.
Trial 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… 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, Dexamethasone and Pomalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 59 sitesin 8 countries
- Study dates
- 15 Apr 2026to 30 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
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- 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.
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
59 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 8 countries
Japan13 sites, 13 recruiting
- Recruiting
GSK Investigational Site
Aichi, 467-8602
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chiba, 277-8567
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ehime, 790-8524
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fukushima, 960-1295
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Gunma, 371-8511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hokkaido, 060-8543
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ishikawa, 920-8641
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Numakunai, 028-3695
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Okayama, 701-1192
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Osaka, 590-0197
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Sendai, 983-8520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 105-8471
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Yamanashi, 409-3898
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United States12 sites, 12 recruiting
- Recruiting
GSK Investigational Site
Baton Rouge, Louisiana, 70809
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Bethesda, Maryland, 20817
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Bridgeton, Missouri, 63044
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Farmington, New Mexico, 87401
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fort Myers, Florida, 33912
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Los Alamitos, California, 90720
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Macon, Georgia, 31210
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Norwich, Connecticut, 06360
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Springfield, Missouri, 65807
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Torrance, California, 90505
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Whittier, California, 90602
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain9 sites, 9 recruiting
- Recruiting
GSK Investigational Site
Badalona, 08916
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Córdoba, 14004
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Gijón, 33394
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Jerez de la Frontera, Andalusia, 11407
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28006
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Málaga, 29010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salamanca, 37007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Vitoria-Gasteiz, 01009
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Dunkirk, Nord, 59240
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nantes, 44093
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Paris, 75012
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Paris, 75475
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Paris, 75651
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Saint-Etienne
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03722
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 110-774
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 137701
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 138-736
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ulsan, 44033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Germany5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Frankfurt, 60389
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hamburg, 22763
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Karlsruhe, 76133
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Koblenz, 56068
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
München, 80634
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Greece5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Athens, 106 76
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Athens, 11528
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Periohi Dragana Alexand, 68100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Thessaloniki, Central Macedonia, 570 10
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Thessaloniki, 54007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Netherlands3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Amersfoort, 3813 TZ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hoofddorp, 2130 AT
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
The Hague, 2545 AA
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Belantamab mafodotin, Dexamethasone, Pomalidomide, Bortezomib, Carfilzomib
- Keywords
- Relapsed-Refractory Multiple Myeloma, DREAMM-15, Belantamab Mafodotin, Blenrep, Pomalidomide, Bortezomib, Carfilzomib, Dexamethasone
- 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
Also called Blenrep
Belantamab mafodotin will be administered.
DexamethasoneDrug
Dexamethasone will be administered.
PomalidomideDrug
Also called Imnovid
Pomalidomide will be administered.
BortezomibDrug
Also called Velcade
Bortezomib will be administered.
CarfilzomibDrug
Also called Kyprolis
Carfilzomib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd) | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Pomalidomide |
| Belantamab mafodotin + Bortezomib + Dexamethasone (BVd) | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib |
| Belantamab mafodotin + Carfilzomib + dexamethasone (BKd) | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 52 months
Secondary outcomes (7)
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).
Measured: Up to approximately 52 months
Minimal Residual Disease (MRD) Negativity Rate
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.
Measured: Up to approximately 52 months
Duration of Response (DoR)
DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.
Measured: Up to approximately 52 months
Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity
Measured: Up to approximately 52 months
Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation
Measured: Up to approximately 52 months
Number of Participants With Ocular Findings on Ophthalmic Examination by severity
Measured: Up to approximately 52 months
Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings
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.
Measured: Up to approximately 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start15 Apr 2026
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227311
- Sponsor's protocol ID
- 224317
- Other IDs
- 2025-523117-28-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07227311
- Acronym / sponsor ID
- 224317
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed-Refractory Multiple Myeloma, DREAMM-15, Belantamab Mafodotin, Blenrep, Pomalidomide, Bortezomib, Carfilzomib, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
Key exclusion criteria (35 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinAlso: BlenrepBelantamab mafodotin will be administered. | Drug | Belantamab mafodotin + Bortezomib + Dexamethasone (BVd), Belantamab mafodotin + Carfilzomib + dexamethasone (BKd), Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd) |
| DexamethasoneDexamethasone will be administered. | Drug | Belantamab mafodotin + Bortezomib + Dexamethasone (BVd), Belantamab mafodotin + Carfilzomib + dexamethasone (BKd), Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd) |
| PomalidomideAlso: ImnovidPomalidomide will be administered. | Drug | Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd) |
| BortezomibAlso: VelcadeBortezomib will be administered. | Drug | Belantamab mafodotin + Bortezomib + Dexamethasone (BVd) |
| CarfilzomibAlso: KyprolisCarfilzomib will be administered. | Drug | Belantamab mafodotin + Carfilzomib + dexamethasone (BKd) |
Primary outcome
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.
7 secondary outcomes
Complete Response Rate (CRR)
Time frame: Up to approximately 52 months
Minimal Residual Disease (MRD) Negativity Rate
Time frame: Up to approximately 52 months
Duration of Response (DoR)
Time frame: 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
Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation
Time frame: Up to approximately 52 months
Number of Participants With Ocular Findings on Ophthalmic Examination by severity
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
59 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belantamab mafodotin, Dexamethasone and Pomalidomide in people with Multiple Myeloma, run by GlaxoSmithKline at 59 sites in 8 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 19 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Japan, United States, Spain, France, South Korea and 3 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to approximately 52 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.