A Phase II Randomized Adaptive Platform Trial Evaluating Novel Therapies in Relapsed or Refractory Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Teclistamab Monotherapy
- Conditions
- Relapse Multiple Myeloma
- Sponsor
- Multiple Myeloma Research Consortium
- Enrollment
- 300
- Locations
- 13
- Primary Endpoint
- ORR
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sub-protocol A
Serves as the reference arm for the platform
Intervention: Teclistamab Monotherapy
Sub-Protocol B
This arm will be an investigational arm
Intervention: Teclistamab
Outcomes
Primary Outcomes
ORR
Time Frame: through completion of the study, and yearly
Objective Response Rate