Description:
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.
Title
- Brief Title: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
- 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
Clinical Trial IDs
- ORG STUDY ID:
207503
- NCT ID:
NCT04246047
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Belantamab mafodotin | | Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) |
Daratumumab | | Daratumumab and Bortezomib plus Dexamethasone (Arm B) |
Bortezomib | | Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) |
Dexamethasone | | Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) |
Purpose
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.
Detailed Description
Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd).
Treatment will continue in both arms until progressive disease, death, unacceptable toxicity,
withdrawal of consent or end of study, whichever occurs first.
Trial Arms
Name | Type | Description | Interventions |
---|
Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) | Experimental | | - Belantamab mafodotin
- Bortezomib
- Dexamethasone
|
Daratumumab and Bortezomib plus Dexamethasone (Arm B) | Active Comparator | | - Daratumumab
- Bortezomib
- Dexamethasone
|
Eligibility 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;
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | Up to an average of 34 months |
Safety Issue: | |
Description: | Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. |
Secondary Outcome Measures
Measure: | Complete response rate (CRR) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Percentage of participants with a confirmed complete response or better. |
Measure: | Overall response rate (ORR) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Percentage of participants with a confirmed partial response or better. |
Measure: | Duration of response (DoR) after administration of study treatment |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first. |
Measure: | Time to response (TTR) after administration of study treatment |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better. |
Measure: | Time to Progression (TTP) after administration of study treatment |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first. |
Measure: | Overall survival (OS) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Time from randomization to death due to any cause. |
Measure: | Progression-free survival on subsequent line of therapy (PFS2) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first. |
Measure: | Minimal Residual Disease (MRD) negativity rate after administration of study treatment |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Percentage of participants who are MRD negative by next-generation sequencing. |
Measure: | Number of participants with adverse events (AEs) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | AEs will be collected, including abnormal laboratory parameters. |
Measure: | Number of participants with serious adverse events (SAEs) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | SAEs will be collected. |
Measure: | Number of participants with abnormal ocular findings on ophthalmic examination |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Ophthalmic examination will assess abnormal findings. |
Measure: | Plasma concentrations of belantamab mafodotin at indicated time points |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Plasma concentrations of belantamab mafodotin in Arm A. |
Measure: | Plasma concentrations of total monoclonal antibody (mAb) at indicated time points |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Plasma concentrations of total mAb in Arm A. |
Measure: | Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Plasma concentrations of cys-mcMMAF in Arm A. |
Measure: | Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Plasma concentrations of belantamab mafodotin ADAs in Arm A. |
Measure: | Titers of ADAs against belantamab mafodotin |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | Titers of ADAs in Arm A. |
Measure: | 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 |
Safety Issue: | |
Description: | PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score. |
Measure: | Change from Baseline in impacts as measured by PRO-CTCAE |
Time Frame: | Baseline and Up to 74 months |
Safety Issue: | |
Description: | PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score. |
Measure: | 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 |
Safety Issue: | |
Description: | 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. |
Measure: | Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20) |
Time Frame: | Baseline and Up to 74 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | GlaxoSmithKline |
Trial Keywords
- Belantamab mafodotin
- Relapsed/refractory multiple myeloma
- Daratumumab
- Bortezomib
- Dexamethasone
Last Updated
July 22, 2021