Evaluating BCD-264 and Darzalex for treating relapsed multiple myeloma
A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma
This study is testing whether a new treatment called BCD-264 works better than Darzalex for patients with relapsed multiple myeloma who have already tried other therapies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biocad Industry-sponsored |
| Drugs / interventions | daratumumab |
| Locations | 14 sites (Chelyabinsk and 13 other locations) |
| Trial ID | NCT06296121 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of two treatments, BCD-264 and Darzalex, in patients with relapsed and refractory multiple myeloma who have previously been treated with proteasome inhibitors and immunomodulatory drugs. Participants will receive either BCD-264 or Darzalex as monotherapy to assess their response to treatment. The study will include patients who have measurable disease and have shown at least a partial response to prior therapies. The goal is to determine which treatment is more effective for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of relapsed and refractory multiple myeloma who have previously received specific therapies.
Not a fit: Patients who have previously been treated with daratumumab or other anti-CD38 therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed and refractory multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar therapies for multiple myeloma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chelyabinsk and 13 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.