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)
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|ClinicalTrials.gov Identifier: NCT04246047|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2020
Last Update Posted : February 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Belantamab mafodotin Drug: Daratumumab Drug: Bortezomib Drug: Dexamethasone||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||575 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This is an open-label study; therefore, no blinding of treatment identity is needed.|
|Official Title:||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|
|Actual Study Start Date :||May 7, 2020|
|Estimated Primary Completion Date :||July 28, 2023|
|Estimated Study Completion Date :||June 19, 2026|
|Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)||
Drug: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Synthetic glucocorticoid with anti-tumor activity
|Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B)||
Anti-cluster of differentiation 38 [CD-38] monoclonal antibody
Synthetic glucocorticoid with anti-tumor activity
- Progression-free survival [ Time Frame: Up to an average of 34 months ]Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
- Complete response rate (CRR) [ Time Frame: Up to 74 months ]Percentage of participants with a confirmed complete response or better.
- Overall response rate (ORR) [ Time Frame: Up to 74 months ]Percentage of participants with a confirmed partial response or better.
- Duration of response (DoR) after administration of study treatment [ Time Frame: Up to 74 months ]Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
- Time to response (TTR) after administration of study treatment [ Time Frame: Up to 74 months ]Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.
- Time to Progression (TTP) after administration of study treatment [ Time Frame: Up to 74 months ]Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: Up to 74 months ]Time from randomization to death due to any cause.
- Progression-free survival on subsequent line of therapy (PFS2) [ Time Frame: Up to 74 months ]Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.
- Minimal Residual Disease (MRD) negativity rate after administration of study treatment [ Time Frame: Up to 74 months ]Percentage of participants who are MRD negative by next-generation sequencing.
- Number of participants with adverse events (AEs) [ Time Frame: Up to 74 months ]AEs will be collected, including abnormal laboratory parameters.
- Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 74 months ]SAEs will be collected.
- Number of participants with abnormal ocular findings on ophthalmic examination [ Time Frame: Up to 74 months ]Ophthalmic examination will assess abnormal findings.
- Plasma concentrations of belantamab mafodotin at indicated time points [ Time Frame: Up to 74 months ]Plasma concentrations of belantamab mafodotin in Arm A.
- Plasma concentrations of total monoclonal antibody (mAb) at indicated time points [ Time Frame: Up to 74 months ]Plasma concentrations of total mAb in Arm A.
- Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points [ Time Frame: Up to 74 months ]Plasma concentrations of cys-mcMMAF in Arm A.
- Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to 74 months ]Plasma concentrations of belantamab mafodotin ADAs in Arm A.
- Titers of ADAs against belantamab mafodotin [ Time Frame: Up to 74 months ]Titers of ADAs in Arm A.
- Change from Baseline in symptoms as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: Baseline and Up to 74 months ]PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score.
- Change from Baseline in impacts as measured by PRO-CTCAE [ Time Frame: Baseline and Up to 74 months ]PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.
- Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30) [ Time Frame: Baseline and Up to 74 months ]EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
- Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20) [ Time Frame: Baseline and Up to 74 months ]EORTC 20-item Multiple Myeloma Module QLQ-MY20 questionnaire: only Disease Symptoms Domain will be administered. A high score represents a high level of symptoms or problems.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246047
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|
|Other Study ID Numbers:||
|First Posted:||January 29, 2020 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||IPD for this study will be made available via the Clinical Study Data Request site.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study|
|Access Criteria:||Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Relapsed/refractory multiple myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal