A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocad

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 disease, who have received one prior line of therapy that included a proteasome inhibitor and lenalidomide and were refractory to lenalidomide, or who have received two or three prior lines of therapy that included a proteasome inhibitor and lenalidomide, with disease progression during or after the last line of therapy.

Eligibility criteria

Qualifiers

Signed informed consent form.

Age ≥18 years.

Documented diagnosis of multiple myeloma according to the IMWG criteria.

Measurable disease at screening.

Disqualifiers

Prior therapy with anti-BCMA or anti-CD3 drugs, pomalidomide.

Refractory to anti-CD38 monoclonal antibodies according to the IMWG criteria.

Use of any investigational products or medical devices within 28 days prior to randomization or planned use of investigational products or medical devices during participation in this study.

Hematopoietic stem cell transplantation - prior to randomization or planned during the study

Trial design

Treatments tested in this trial

  • BCD-248 + daratumumab
  • Daratumumab + pomalidomide + dexamethasone

Treatment groups

390 Participants
are divided into 2 treatment groups

Sponsors and collaborators