Clinical trial NCT06868667: Japan Expansion Cohort: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Japan Expansion Cohort
Belantamab mafodotin
Relapsed/refractory multiple myeloma
Daratumumab
Bortezomib
Dexamethasone
Multiple Myeloma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Japanese participants with relapsed refractory multiple myeloma.


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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 32 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 255 weeks
measure: Duration of Response (DoR)
timeFrame: Up to 255 weeks
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to 255 weeks
measure: Complete Response Rate (CRR)
timeFrame: Up to 255 weeks
measure: Overall Response Rate (ORR)
timeFrame: Up to 255 weeks
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 255 weeks
measure: Time to Response (TTR)
timeFrame: Up to 255 weeks
measure: Time to Progression (TTP)
timeFrame: Up to 255 weeks
measure: Progression-free Survival on Subsequent Line of Therapy (PFS2)
timeFrame: Up to 255 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 255 weeks
measure: Number of Participants With Clinically Significant Changes in Hematology Parameters
timeFrame: Up to 255 weeks
measure: Number of Participants With Clinically Significant Changes in Clinical Chemistry
timeFrame: Up to 255 weeks
measure: Number of Participants With Clinically Significant Changes in Urine Dipstick
timeFrame: Up to 255 weeks
measure: Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
timeFrame: Up to 255 weeks
measure: Plasma Concentrations of Belantamab Mafodotin (Total Antibody)
timeFrame: Up to 255 weeks
measure: Plasma Concentrations of Belantamab Mafodotin (ADC)
timeFrame: Up to 255 weeks
measure: Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF)
timeFrame: Up to 255 weeks
measure: Number of Participants With Positive Anti-Drug Antibodies (ADAs) Against Belantamab Mafodotin
timeFrame: Up to 255 weeks
measure: Titers of ADAs Against Belantamab Mafodotin
timeFrame: Up to 255 weeks
measure: 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 255 weeks
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)
timeFrame: Up to 255 weeks
measure: Change From Baseline in HRQoL as Measured by EORTC IL52
timeFrame: Up to 255 weeks
Other outcomes:
Locations:
city: Aomori
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Himeji
country: Japan
facility: GSK Investigational Site
city: Kamakura
country: Japan
facility: GSK Investigational Site
city: Kitakyushu
country: Japan
facility: GSK Investigational Site
city: Kochi
country: Japan
facility: GSK Investigational Site
city: Matsuyama
country: Japan
facility: GSK Investigational Site
city: Nagoya
country: Japan
facility: GSK Investigational Site
city: Ogaki
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shibukawa
country: Japan
facility: GSK Investigational Site
city: Sunto-gun
country: Japan
facility: GSK Investigational Site
city: Suwa
country: Japan
facility: GSK Investigational Site
city: Toyohashi
country: Japan
facility: GSK Investigational Site
city: Yokohama
country: Japan
facility: GSK Investigational Site
Study officials:
References: