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Brief Summary:
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.
| 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 ...
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| Study Type : | Interventional (Clinical Trial) |
| ActualEnrollment : | 571 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Primary Completion Date : | October 2, 2023 |
| Estimated Study Completion Date : | June 19, 2026 |
Resource links provided by the National Library of Medicine 
MedlinePlus Genetics related topics: Multiplemyeloma
MedlinePlus related topics: MultipleMyeloma
Drug Information available for: Dexamethasone Dexamethasonesodiumphosphate Dexamethasoneacetate Bortezomib Daratumumab Belantamab
Genetic and Rare Diseases Information Center resources: MultipleMyeloma
U.S. FDA Resources
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) | Drug: Belantamab mafodotin Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate Drug: Bortezomib Proteasome Inhibitor Drug: Dexamethasone Synthetic glucocorticoid with anti-tumor activity |
| Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B) | Drug: Daratumumab Anti-cluster of differentiation 38 [CD-38] monoclonal antibody Drug: Bortezomib Proteasome Inhibitor Drug: Dexamethasone Synthetic glucocorticoid with anti-tumor activity |
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Primary Outcome Measures :
- Progression-free survival [TimeFrame:Up to an average of 37 months]
Time from the date of randomization until the earliest date of to the first documented disease progression or death due to any cause, whichever occurs first
Secondary Outcome Measures :
- Complete response rate (CRR) [TimeFrame:Up to 74 months]
Percentage of participants with a confirmed complete response or better.
- Overall response rate (ORR) [TimeFrame:Up to 74 months]
Percentage of participants with a confirmed partial response or better.
- Clinical Benefit Rate (CBR) [TimeFrame:Up to 74 months]
Percentage of participants with a confirmed partial response or better
- Duration of response (DoR) [TimeFrame: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) [TimeFrame:Up to 74 months]
Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.
- Time to Progression (TTP) [TimeFrame:Up to 74 months]
Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.
- Overall survival (OS) [TimeFrame:Up to 74 months]
Time from the date of randomization until the date of death due to any cause.
- Progression-free survival on subsequent line of therapy (PFS2) [TimeFrame:Up to 74 months]
Time from start of study treatment to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier .
- Minimal Residual Disease (MRD) negativity rate [TimeFrame:Up to 74 months]
Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next generation sequencing (NGS)
- Number of participants with adverse events (AEs) [TimeFrame:Up to 74 months]
AEs will be collected, including abnormal laboratory parameters.
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters [TimeFrame:Up to 74 months]
- Number of participants with abnormal ocular findings on ophthalmic examination [TimeFrame:Up to 74 months]
Ophthalmic examination will assess abnormal findings.
- Plasma concentrations of belantamab mafodotin at indicated time points [TimeFrame:Up to 74 months]
Plasma concentrations of belantamab mafodotin in Arm A.
- Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points [TimeFrame:Up to 74 months]
Plasma concentrations of cys-mcMMAF in Arm A.
- Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [TimeFrame:Up to 74 months]
Plasma concentrations of belantamab mafodotin ADAs in Arm A.
- Titers of ADAs against belantamab mafodotin [TimeFrame:Up to 74 months]
Titers of ADAs in Arm A.
- Number of Participants with Maximum post-baseline change from baseline in individual items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) [TimeFrame:Up to 74 months]
PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a 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) [TimeFrame: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 IL52, 20-Item Multiple Myeloma Module (QLQ-MY20) [TimeFrame:Baseline and Up to 74 months]
EORTC IL52 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.
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Information from the National Library of Medicine
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 |
Criteria
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;
- 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
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.
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Top of Page Study Description Study Design
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Information from the National Library of Medicine
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
Locations
Show 151 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT04246047 |
| Other Study ID Numbers: | 207503 2018-003993-29 ( EudraCT Number ) |
| First Posted: | January 29, 2020 Key Record Dates |
| Last Update Posted: | December 13, 2023 |
| Last Verified: | December 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. |
| Supporting Materials: | Study Protocol 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. |
| URL: | http://clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by GlaxoSmithKline:
| Belantamab mafodotin Relapsed/refractory multiple myeloma Daratumumab | Bortezomib Dexamethasone Multiple Myeloma |
Additional relevant MeSH terms:
| Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases | Dexamethasone Bortezomib Daratumumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
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