Trials / Recruiting
RecruitingNCT06296121
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCD-264 | IV, 16 mg/kg |
| DRUG | Darzalex | IV, 16 mg/kg |
Timeline
- Start date
- 2023-12-21
- Primary completion
- 2025-01-01
- Completion
- 2026-07-01
- First posted
- 2024-03-06
- Last updated
- 2024-03-06
Locations
14 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT06296121. Inclusion in this directory is not an endorsement.