NCT06868654Active, not recruitingPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Belantamab mafodotin and Bortezomib plus Dexamethasone
Experimental
Intervention: Belantamab mafodotin (Drug)
Belantamab mafodotin and Bortezomib plus Dexamethasone
Experimental
Intervention: Bortezomib (Drug)
Belantamab mafodotin and Bortezomib plus Dexamethasone
Experimental
Intervention: Dexamethasone (Drug)
Daratumumab and Bortezomib plus Dexamethasone
Active Comparator
Intervention: Daratumumab (Drug)
Daratumumab and Bortezomib plus Dexamethasone
Active Comparator
Intervention: Bortezomib (Drug)
Daratumumab and Bortezomib plus Dexamethasone
Active Comparator
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Up to approximately 32 months
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Secondary Outcomes
- Overall Survival (OS)(Up to 255 weeks)
- Duration of Response (DoR)(Up to 255 weeks)
- Minimal Residual Disease (MRD) Negativity Rate(Up to 255 weeks)
- Complete Response Rate (CRR)(Up to 255 weeks)
- Overall Response Rate (ORR)(Up to 255 weeks)
- Clinical Benefit Rate (CBR)(Up to 255 weeks)
- Time to Response (TTR)(Up to 255 weeks)
- Plasma Concentrations of Belantamab Mafodotin (Total Antibody)(Up to 255 weeks)
- Plasma Concentrations of Belantamab Mafodotin (ADC)(Up to 255 weeks)
- Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF)(Up to 255 weeks)
- Number of Participants With Clinically Significant Changes in Urine Dipstick(Up to 255 weeks)
- Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination(Up to 255 weeks)
- Time to Progression (TTP)(Up to 255 weeks)
- Progression-free Survival on Subsequent Line of Therapy (PFS2)(Up to 255 weeks)
- Number of Participants With Adverse Events (AEs)(Up to 255 weeks)
- Number of Participants With Clinically Significant Changes in Hematology Parameters(Up to 255 weeks)
- Number of Participants With Clinically Significant Changes in Clinical Chemistry(Up to 255 weeks)
- Number of Participants With Positive Anti-Drug Antibodies (ADAs) Against Belantamab Mafodotin(Up to 255 weeks)
- Titers of ADAs Against Belantamab Mafodotin(Up to 255 weeks)
- 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)(Up to 255 weeks)
- 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)(Up to 255 weeks)
- Change From Baseline in HRQoL as Measured by EORTC IL52(Up to 255 weeks)
Investigators
Study Sites (1)
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