Actively Recruiting
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
Led by Biocad · Updated on 2024-03-06
252
Participants Needed
14
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at the time of consent
- Documented diagnosis of multiple myeloma according to IMWG criteria
- Measurable disease at screening with M-protein in serum ≥ 1.0 g/dL or in 24-hour urine ≥ 200 mg, or light chain myeloma with involved serum FLC level ≥ 10 mg/dL and abnormal kappa/lambda FLC ratio
- At least a partial response to at least 1 prior therapy line according to IMWG criteria
- Relapsed and refractory multiple myeloma with prior treatment using proteasome inhibitors and immunomodulatory drugs, and disease progression on prior therapy
- ECOG performance status score between 0 and 2
- Not pregnant and willing to use contraception
- Consent to bone marrow biopsy during the study
You will not qualify if you...
- Prior treatment with daratumumab or other anti-CD38 therapy
- Treatment for multiple myeloma within 2 weeks or 5 half-lives before randomization, except short-term glucocorticoids
- Autologous hematopoietic stem cell transplantation within 12 weeks before randomization
- Any prior allogeneic hematopoietic stem cell transplantation
- Scheduled hematopoietic stem cell transplantation before disease progression during the study
- Diagnosis of plasma cell leukemia, POEMS syndrome, or amyloidosis
- Waldenstrom macroglobulinemia or other diseases with high monoclonal IgM without plasma cell clonal proliferation and lytic bone involvement
- History of other malignancies within 5 years except certain treated non-invasive cancers with minimal recurrence risk
- Plasmapheresis within 28 days before randomization
- Clinical signs of meningeal involvement of multiple myeloma
- Pregnancy, breastfeeding, or planning pregnancy during the study and within 3 months after last dose; males planning to conceive during study and within 3 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia
Actively Recruiting
2
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Kemerovo, Russia
Actively Recruiting
3
Regional Clinical Hospital
Krasnoyarsk, Russia
Actively Recruiting
4
Moscow City Clinical Hospital 52
Moscow, Russia
Actively Recruiting
5
S.P. Botkin Moscow City Clinical Hospital
Moscow, Russia
Actively Recruiting
6
Almazov National Medical Research Centre
Saint Petersburg, Russia
Actively Recruiting
7
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg, Russia
Actively Recruiting
8
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Saint Petersburg, Russia
Actively Recruiting
9
St Petersburg State I.P. Pavlov Medical University
Saint Petersburg, Russia
Actively Recruiting
10
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Actively Recruiting
11
Samara State Medical University
Samara, Russia
Actively Recruiting
12
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Sochi, Russia
Actively Recruiting
13
Bashkir State Medical University
Ufa, Russia
Actively Recruiting
14
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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