NCT06868654Active, not recruitingPhase 3
China Subpopulation: 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
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 6 Mar 2025
- Start date
- 28 Jul 2021
- Primary completion date
- 3 Apr 2024
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Multiple myeloma
- NCT number
- NCT06868654
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 72
- From 28 Jul 2021 to the primary completion date, 3 Apr 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
- Prior allogenic stem cell transplant.
Other illness
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
- Corneal epithelial disease
Other
- Intolerant to daratumumab.
- Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
Who the study is looking for
- 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;
- Urine M-protein excretion \>=200 mg per 24-hour, or
- Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| - Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.