A Phase II Randomized Adaptive Platform Trial Evaluating Novel Therapies in Relapsed or Refractory Multiple Myeloma
Multiple Myeloma Research Consortium
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria For inclusion in the trial, all the following inclusion criteria must be fulfilled, as no waivers will be permitted: * Voluntarily agree to participate by giving written informed consent * ≥18 years of age * Histologically confirmed multiple myeloma that is exposed, relapsed, or intolerant to one of each of the following classes of agents: * A proteasome inhibitor * An immunomodulatory drug * An anti-CD38-monoclonal antibody * Must have received between 1-4 lines of prior systemic therapy * Prior BCMA-directed antibody-drug conjugate (ADC) or chimeric antigen re…
Interventions
- DrugTeclistamab Monotherapy
standard of care
- DrugTeclistamab
investigational doses compared to SOC
Locations (13)
- City of HopeDuarte, California
- Emory Winship Cancer CenterAtlanta, Georgia
- University of Chicago Cancer CenterChicago, Illinois
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer Institute/Harvard Medical SchoolBoston, Massachusetts
- Barbara Ann Karmanos Cancer CenterDetroit, Michigan