RecruitingMultiple Myeloma
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
Eligible age
18–72 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 1. 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
- ✓ 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
You may not qualify if…
- ✕ 1. Progression of myeloma, as defined by the IMWG criteria (Appendix C), prior to initiation of maintenance therapy
- ✕ 2. 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.
- ✕ 3. 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.
- ✕ 4. Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
- ✕ 5. Participants must not have an active infection requiring treatment.
- ✕ 6. 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.
- ✕ 7. Major surgery within 4 weeks before initiating study treatment.
- ✕ 8. HIV-positive patients and/or active hepatitis A, B or C infections.
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT05776979 · last updated 2026-06-08