Table 4.
A summary table on the ongoing clinical trials assessing cilta-cel safety and efficacy in the treatment of MM under various conditions.
| Clinical study | Trial number | Purpose | Clinical sites | Patient number | Phase/Status |
|---|---|---|---|---|---|
| CARTITUDE-1 (69) | NCT03548207 | Evaluating the safety and efficacy of cilta-cel in adults with r/r MM who received ≥3 prior LOT (PI, an IMiDs, and anti-CD38 mAb) | 16 | 97 | Phase1b/2; data published; cilta-cel approved for this type of r/r MM, but still active |
| CARTITUDE-2 (70) | NCT04133636 | Assessing cilta-cel efficacy and safety in patients who had progressive MM after 1-3 prior LOT and were refractory to lenalidomide (Cohort A), early relapse after initial therapy (cohort B), r/r MM after PI, anti-CD38 antibody, an IMiD, and BCMA-directed treatment (cohort C), Less than CR after ASCT front-line therapy (cohort D), NDMM with the high-risk disease after no or only one cycle of prior therapy (cohort E), NDMM with standard-risk (ISS stage I and II) and after initiation of therapy (cohort F) | 45 | 157 | Phase 2, data from cohort A and B are published (45, 47, 48), but they are still ongoing, while other cohorts are in progress (not yet recruited patients) |
| CARTITUDE-4 (71) | NCT04181827 | Compare cilta-cel safety and efficacy versus standard LOTs in adult patients with relapsed and lenalidomide refractory MM. | 100 | 400 | Phase 3; Active but not yet recruiting |
| CARTITUDE-5 (72) | NCT04923893 | Assess the efficacy and safety of cilta-cel as a frontline therapy in patients with NDMM not intended for transplant. | 118 | 650 | Phase 3; recruiting patients |
| CARTITUDE-6 (73) | NCT05257083 | Compare the efficacy and safety of DVRd followed by a single infusion of cilta-cel versus DVRd followed by ASCT in patients with NDMM who are not exposed to prior BCMA targeted therapy. | 52 | 750 | Phase 3; Patients recruitment has not yet started |
ASCT, autologous stem cell transplant; DVRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; IMiDs, immunomodulatory drugs; ISS, international staging system; LOT, line of therapy; mAb, monoclonal antibody; MM, multiple myeloma; NDMM, newly diagnosed MM; PI, protease inhibitor.