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

NCT06296121 | Recruiting Phase 3

• 1 other identifier: BCD-264-2
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 14

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate according to IMWG (International Myeloma Working Group) criteria

  up to 24 weeks

Secondary Outcomes (8)

• 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

• Duration of response

  up to 3 years

• Progression-free survival

  up to 3 years

Other Outcomes (12)

• Incidence and characteristics of adverse events

  up to 2 years

• Proportion of subjects with BAbs/Nabs

  up to 2 years

• Time to BAb/NAb development

  up to 2 years

Study Arms (2)

BCD-264

EXPERIMENTAL

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

Drug: BCD-264

Darzalex

ACTIVE COMPARATOR

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

Drug: Darzalex

Interventions

BCD-264 DRUG

IV, 16 mg/kg

Also known as: daratumumab

BCD-264

Darzalex DRUG

IV, 16 mg/kg

Also known as: daratumumab

Darzalex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age ≥ 18 years at the time of signing of the informed consent form.
• Documented diagnosis of multiple myeloma according to IMWG criteria
• Measurable disease at screening:
• M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
• light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .
• At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
• 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
• ECOG score 0-2.
• Not pregnant and willing to use contraception.
• Consent to bone marrow biopsy in the study.

You may not qualify if:

• Prior treatment with daratumumab or other anti-CD38 therapy.
• Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
• Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
• Allogeneic hematopoietic stem cell transplantation, regardless of timing.
• Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
• Plasma cell leukemia, POEMS syndrome or amyloidosis.
• 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.
• 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.
• Plasmapheresis within 28 days prior to randomization.
• Clinical signs of meningeal involvement of multiple myeloma.
• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (14)

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, Russia

RECRUITING

Kuzbass Regional Clinical Hospital named after S.V. Belyaev

Kemerovo, Russia

RECRUITING

Regional Clinical Hospital

Krasnoyarsk, Russia

RECRUITING

Moscow City Clinical Hospital 52

Moscow, Russia

RECRUITING

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

RECRUITING

Almazov National Medical Research Centre

Saint Petersburg, Russia

RECRUITING

N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg, Russia

RECRUITING

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

Saint Petersburg, Russia

RECRUITING

St Petersburg State I.P. Pavlov Medical University

Saint Petersburg, Russia

RECRUITING

State budgetary healthcare institution Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

RECRUITING

Samara State Medical University

Samara, Russia

RECRUITING

Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

Sochi, Russia

RECRUITING

Bashkir State Medical University

Ufa, Russia

RECRUITING

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, Russia

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 6, 2024
• Study Start: December 21, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)