A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)
Recruiting
Phase 3
Interventional Study
Myeloma Multiple
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 390 (estimated)
- Sponsor
- Biocad · Industry
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About This Trial
The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma. The study will be conducted in a population of male and female subjects aged 18 years and older, with confirmed symptomatic multiple myeloma with measurable diseas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent form.
* Age ≥18 years.
* Documented diagnosis of multiple myeloma according to the IMWG criteria.
* Measurable disease at screening.
* At least 1, but not more than 3 prior lines of antimyeloma therapy, including lenalidomide and a proteasome inhibitor.…
Contacts