Actively Recruiting
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Led by M.D. Anderson Cancer Center · Updated on 2025-11-19
61
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
CONDITIONS
Official Title
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 72 years with newly diagnosed symptomatic multiple myeloma
- Measurable disease at diagnosis defined by serum or urine M-protein levels, or imaging for non-secretory myeloma
- High-risk myeloma defined by specific staging or genetic abnormalities
- Karnofsky performance score of at least 70% or ECOG performance status 2 or less
- Underwent autologous stem cell transplant with melphalan or busulfan plus melphalan conditioning and adequate blood count recovery
- Achieved at least partial response before starting maintenance therapy
- Adequate organ function including kidney, liver, and blood tests
- Provided written informed consent
- Female participants must not be pregnant or lactating and must use effective birth control or abstain during and after treatment
- Male participants must agree to birth control and refrain from sperm donation during and after treatment
You will not qualify if you...
- Progression of myeloma before starting maintenance therapy
- Receiving other investigational agents within 14 days or 5 half-lives prior to study start
- History of allergic reactions to study drugs or their components not manageable with premedication
- Hypersensitivity or rash to thalidomide or lenalidomide
- Active infections requiring treatment
- Uncontrolled illnesses including severe hypertension, symptomatic heart failure, acute coronary syndrome, liver cirrhosis, or cognitive/psychiatric/social conditions limiting compliance
- Major surgery within 4 weeks before study treatment
- HIV-positive or active hepatitis A, B, or C infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Muzzaffar Qazilbash, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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