Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
2 other identifiers
interventional
61
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
August 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 19, 2025
November 1, 2025
4.4 years
March 8, 2023
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
through study completion; an average of 1 year.
Study Arms (1)
isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT)
EXPERIMENTALBoth isatuximab and lenalidomide are FDA approved and commercially available for the treatment of relapsed or refractory MM (MM that has come back or stopped responding to treatment). Participants will begin taking the study drugs about 60-180 days after your ASCT. Participants may receive the study drugs for about 3 years. After that, participants will have follow-up visits 1 time a year for the 3 years after your last dose of study drugs
Interventions
Given by vein over about 75 minutes
Given by PO
Eligibility Criteria
You may qualify if:
- 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
- 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
- English and non-English speaking patients are eligible.
- Karnofsky performance score of at least 70% and/or ECOG PS ≤2
- 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
- +9 more criteria
You may not qualify if:
- Progression of myeloma, as defined by the IMWG criteria (Appendix C), prior to initiation of maintenance therapy
- 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.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
- Participants must not have an active infection requiring treatment.
- Participants must not have an uncontrolled intercurrent illness including, but not limited to, an uncontrolled hypertension (systolic \>170, diastolic \>100 despite antihypertensive therapy), symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association (NYHA) functional classification system), acute coronary syndrome, liver cirrhosis, and/or cognitive impairments/psychiatric illness/social situations that would limit compliance with study requirements. PI is the final arbiter of this criterion.
- Major surgery within 4 weeks before initiating study treatment.
- HIV-positive patients and/or active hepatitis A, B or C infections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Sanoficollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muzzaffar Qazilbash, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 20, 2023
Study Start
August 17, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 19, 2025
Record last verified: 2025-11