A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Mul
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available.
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below. |
| Who can participate | Inclusion Criteria: * Diagnosed with MM per International Myeloma Working Group (IMWG) criteria * Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2 * Resolution of AEs from prior anti-cancer therapy to Grade \<=1 * Agreement to undergo scheduled assessments and procedures Additional Inclusion Criteria for SS2: * Completion of planned induction therapy and achievement of at least a partial response (PR) * Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease * Cytogenetic high-risk features at diagnosis * Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hoffmann-La Roche |
| Locations | Randwick, New South Wales, Australia; Fitzroy, Victoria, Australia; Pierre-Bénite, France; Toulouse, France; Tours, France; Villejuif, France (+10 more sites) |
| Start date | 2023-11-14 |
| NCT ID | NCT05583617 |
| Official listing | https://clinicaltrials.gov/study/NCT05583617 |