A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

Phase 3

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Darzalex; Drug: BCD-264

• Registration Number: NCT06296121
• Lead Sponsor: Biocad

Brief Summary

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Signed informed consent form.

2. Age ≥ 18 years at the time of signing of the informed consent form.

3. Documented diagnosis of multiple myeloma according to IMWG criteria

4. Measurable disease at screening:

   1. M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
   2. light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .

5. At least a partial response according to IMWG criteria to at least 1 prior line of therapy.

6. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy

7. ECOG score 0-2.

8. Not pregnant and willing to use contraception.

9. Consent to bone marrow biopsy in the study.

Exclusion Criteria

1. Prior treatment with daratumumab or other anti-CD38 therapy.
2. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
4. Allogeneic hematopoietic stem cell transplantation, regardless of timing.
5. Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
6. Plasma cell leukemia, POEMS syndrome or amyloidosis.
7. Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement.
8. A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years.
9. Plasmapheresis within 28 days prior to randomization.
10. Clinical signs of meningeal involvement of multiple myeloma.
11. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darzalex	Darzalex	Blinded period: Darzalex (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles. Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
BCD-264	BCD-264	Blinded period: BCD-264 (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles. Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks

Primary Outcome Measures

Name	Time	Method
Overall response rate according to IMWG (International Myeloma Working Group) criteria	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Duration of response	up to 3 years
Progression-free survival	up to 3 years
Time to response	up to 3 years
Stringent complete response rate according to IMWG criteria	up to 3 years
Complete response (CR) rate according to IMWG criteria	up to 3 years
Very good partial response (VGPR) rate according to IMWG criteria	up to 3 years
Time to progression	up to 3 years
Overall survival	up to 3 years

Trial Locations

Locations (14)

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency; 🇷🇺 Saint Petersburg, Russian Federation

Chelyabinsk Regional Clinical Hospital; 🇷🇺 Chelyabinsk, Russian Federation

Kuzbass Regional Clinical Hospital named after S.V. Belyaev; 🇷🇺 Kemerovo, Russian Federation

Moscow City Clinical Hospital 52; 🇷🇺 Moscow, Russian Federation

Sverdlovsk Regional Clinical Hospital No. 1; 🇷🇺 Ekaterinburg, Russian Federation

Regional Clinical Hospital; 🇷🇺 Krasnoyarsk, Russian Federation

N.N. Petrov National Medicine Research Center of oncology; 🇷🇺 Saint Petersburg, Russian Federation

Samara State Medical University; 🇷🇺 Samara, Russian Federation

Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory; 🇷🇺 Sochi, Russian Federation

State budgetary healthcare institution Leningrad Regional Clinical Hospital; 🇷🇺 Saint Petersburg, Russian Federation

S.P. Botkin Moscow City Clinical Hospital; 🇷🇺 Moscow, Russian Federation

Almazov National Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation

St Petersburg State I.P. Pavlov Medical University; 🇷🇺 Saint Petersburg, Russian Federation

Bashkir State Medical University; 🇷🇺 Ufa, Russian Federation