Phase III study of belantamab mafodotin, bortezomib, and dexamethasone (B-Vd) versus daratumumab, bortezomib, and dexamethasone (D-Vd) in participants with relapsed/refractory multiple myeloma

JRCT ID: jRCT2011210001

Registered date:13/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 05/07/2021
• Target sample size: 478
• Countries of recruitment: United States,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Korea Republic,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Russian Federation,Japan,Spain,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

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

Arm B:
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

Outcome(s)

Primary Outcome

Progression-free survival [ Time Frame: Up to an average of 34 months ]
Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Ishibashi Hideyasu
• Secondary ID(s): NCT04246047