NCT05776979 Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
| NCT ID | NCT05776979 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
Eligibility Criteria
Inclusion Criteria: 1. Adult patients 18 to 72 years old, with newly diagnosed symptomatic (according to the revised 2014 IMWG criteria as summarized in Appendix A) myeloma. Patients must have measurable disease at diagnosis defined by any of the following: * Serum M-protein ≥1 g/dL (for IgA ≥0.5 g/dL) or urine M-protein ≥200 mg/24 hours * For oligosecretory myeloma, involved serum free light chain (FLC) level ≥10 mg/dL, provided serum FLC ratio is abnormal * For non-secretory myeloma, \> 1 focal lesions measurable by imaging 2. Subjects must have high-risk myeloma defined as followed: * R-ISS stage II or III patients (Appendix B) * ISS stage III (Appendix B) * ≥ 3 copies +1q21 in patients with ISS Stage II/III or R-ISS Stage II/III * Presence of del(17p) cytogenetic abnormality regardless of ISS/R-ISS Stage * Presence of at least 2 high-risk genetic abnormalities \[del(17p), t(4;14), t(14;16), t(14;20), +1q21\] regardless of ISS/R-ISS stage 3. English and non-English speaking patients