A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
NCT ID: NCT06296121
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
252 participants
INTERVENTIONAL
2023-12-21
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
BCD-264
IV, 16 mg/kg
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
Darzalex
IV, 16 mg/kg
Interventions
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BCD-264
IV, 16 mg/kg
Darzalex
IV, 16 mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Locations
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Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , Russia
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Kemerovo, , Russia
Regional Clinical Hospital
Krasnoyarsk, , Russia
Moscow City Clinical Hospital 52
Moscow, , Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg, , Russia
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Saint Petersburg, , Russia
St Petersburg State I.P. Pavlov Medical University
Saint Petersburg, , Russia
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Samara State Medical University
Samara, , Russia
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Sochi, , Russia
Bashkir State Medical University
Ufa, , Russia
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, , Russia
Countries
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Facility Contacts
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Other Identifiers
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BCD-264-2
Identifier Type: -
Identifier Source: org_study_id
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