Isatuximab and Lenalidomide for High-Risk Multiple Myeloma After Transplant
This study is looking into whether a combination of two drugs, isatuximab and lenalidomide, can help control high-risk multiple myeloma (a type of blood cancer) after you've had a stem cell transplant. Isatuximab is given through a vein, and lenalidomide is taken by mouth. The study aims to see if this treatment can prevent the cancer from coming back for at least three years. To join, you must be between 18 and 72 years old, have newly diagnosed multiple myeloma, and show signs of the disease. The study plans to include 61 participants, but its current status is unclear.
- Study design
- This is an interventional study that plans to enroll 61 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events (side effects) through completion, which is an average of one year. Progression-free survival will be measured at 3 years.
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NCT05776979
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Recruiting
PHASE2Ages 18–72InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~61 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Isatuximablenalidomide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
Measured over through study completion; an average of 1 year.
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Muzzaffar Qazilbash, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 are eligible. 4. Karnofsky performance score of at least 70% and/or ECOG PS ≤2 5. Underwent ASCT using a conditioning regimen consisting of single agent Melphalan or a combination of Busulfan and Melphalan with adequate cell count recovery after transplant without the need for growth factor support or transfusions within 7 days from the lab test:
Absolute neutrophil count (ANC) ≥1000 /µL
Hemoglobin ≥8 g/dL
Platelet count ≥50,000 /µL 6. Patients must have achieved partial response (PR) or better prior to starting maintenance therapy. 7. Adequate major organ system function as demonstrated by:
Serum creatinine clearance equal or more than 30 ml/min (calculated with Cockcroft- Gault formula).
Total bilirubin equal or less than 2.0 mg/dL (equal or less than 3.0 mg/dL for patients with Gilbert's disease).
ALT or AST equal or less than 3 times the upper normal for adults. 8. Patient or patient's legal representative, parent(s) or guardian should provide written Internal Review Board (IRB)-approved informed consent. 9. Female patients included must not be pregnant or lactating. Females of childbearing potential must have (before starting treatment) a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours prior to starting Isatuximab and with each cycle of study treatment. Females of childbearing potential must refrain from becoming pregnant and commit to either apply highly effective method of birth control (two reliable methods of birth control) or continue abstinence from heterosexual intercourse during study period and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements. 10. Men of reproductive potential must agree to follow accepted birth control methods and refrain from sperm donation for the duration of the study and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements.
What this trial measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5through study completion; an average of 1 year.