Clinical trial · Interventional
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
NCT04246047CI-TRIAL-00109279DREAMM 7active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belantamab mafodotin | Drug | Belantamab Mafodotin | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Daratumumab | Drug | Daratumumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
- interventionNames
- Drug: Belantamab mafodotin
- Drug: Bortezomib
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Daratumumab and Bortezomib plus Dexamethasone (Arm B)
- interventionNames
- Drug: Daratumumab
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Up to approximately 41 months
- description
- PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. * Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Must have at least 1 aspect of measurable disease, defined as one of the following; 1. Urine M-protein excretion \>=200 mg per 24-hour, or 2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or 3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be \<=Grade 1 at the time of enrollment, except for alopecia. * Adequate organ function Exclusion Criteria: * Intolerant to daratumumab. * Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). * Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. * Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. * Prior allogenic stem cell transplant. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * Corneal epithelial disease.
References
Publications (4)
- DERIVEDMateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949. PMID 40763276
- DERIVEDHungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Martinez GA, Sureda Balari A, Sandhu I, Cerchione C, Ganly P, Dimopoulos MA, Fu C, Garg M, Abdallah AO, Gatt ME, Oriol Rocafiguera A, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Ficek J, Mantero A, Pirooz N, Varghese S, Lee J, McKeown A, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Mukhopadhyay P, Nielsen J, Opalinska J, Mateos MV; DREAMM-7 study investigators. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Aug;26(8):1067-1080. doi: 10.1016/S1470-2045(25)00330-4. Epub 2025 Jul 15. PMID 40680754
- DERIVEDHungria V, Hus M, Fu C, Zherebtsova V, Ward C, Ho PJ, Mikulski D, Muronova L, Cerchione C, Loubert A, Bunod L, M'Hari M, Pirooz N, Rogers R, Lin CP, Roy-Ghanta S, Opalinska JB, Purser M, McKeown A, McNamara S, Baig H, Eccersley L, Pompilus F, Mateos MV; DREAMM-7 trial study group. Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Aug;12(8):e599-e610. doi: 10.1016/S2352-3026(25)00163-2. Epub 2025 Jul 15. PMID 40680752
- DERIVEDHungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Ribas de Almeida AC, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Aparecida Martinez G, Sureda Balari AM, Sandhu I, Cerchione C, Ganly P, Dimopoulos M, Fu C, Garg M, Abdallah AO, Oriol A, Gatt ME, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Pirooz N, McKeown A, McNamara S, Zhou X, Nichols M, Lewis E, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Opalinska J, Mateos MV; DREAMM-7 Investigators. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.