OncoMatch/Clinical Trials/NCT05776979
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Is NCT05776979 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Isatuximab and lenalidomide for multiple myeloma.
Treatment: Isatuximab · lenalidomide — To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Endocrine / hormonal
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: IGH t(4;14)
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
Allowed: IGH t(14;16)
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
Allowed: IGH t(14;20)
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
Allowed: TP53 deletion
Presence of del(17p) cytogenetic abnormality regardless of ISS/R-ISS Stage
Allowed: TP53 deletion
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
Allowed: 1Q21 amplification
≥ 3 copies +1q21 in patients with ISS Stage II/III or R-ISS Stage II/III
Allowed: 1Q21 amplification
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
Demographics
Prior therapy
Must have received: autologous stem cell transplant — post-transplant
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
Cannot have received: investigational agent
Exception: Exceptions can be granted after discussing with PI.
Patients receiving any other investigational agents within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention. Exceptions can be granted after discussing with PI.
Lab requirements
Blood counts
ANC ≥1000/µL; Hemoglobin ≥8 g/dL; Platelet count ≥50,000/µL
Kidney function
Serum creatinine clearance ≥30 ml/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤2.0 mg/dL (≤3.0 mg/dL for patients with Gilbert's disease); ALT or AST ≤3x ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05776979 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 72 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages