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 mafodotinBortezomibDexamethasone
 | 
| Daratumumab and Bortezomib plus Dexamethasone (Arm B) | Active Comparator |  | DaratumumabBortezomibDexamethasone
 | 
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