OncoMatch/Clinical Trials/NCT05776979
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Is NCT05776979 recruiting? Yes, currently enrolling (May 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
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
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 →
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