Multiple MyelomaPhase 2NCT05776979
Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
A Phase 2 study testing Isatuximab and lenalidomide in people with Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT). Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Isatuximab and lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
- Platelet count ≥50,000 /µL
- Patients must have achieved partial response (PR) or better prior to starting maintenance therapy.
- 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.
- Patient or patient's legal representative, parent(s) or guardian should provide written Internal Review Board (IRB)-approved informed consent.
- Female patients included must not be pregnant or lactating. Females of childbearing potential must have (before starting treatment) a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours prior to starting Isatuximab and with each cycle of study treatment. Females of childbearing potential must refrain from becoming pregnant and commit to either apply highly effective method of birth control (two reliable methods of birth control) or continue abstinence from heterosexual intercourse during study period and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements.
- Men of reproductive potential must agree to follow accepted birth control methods and refrain from sperm donation for the duration of the study and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Muzaffar Qazilbash, MD, 713-745-3458, mqazilba@mdanderson.org
Muzaffar Qazilbash, MD
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).
Read the detailed description
Objectives:
Primary Objectives
- Compare progression-free survival at 3 years with historical control rate of 50%.
Primary endpoint
- Progression-free survival at 3 years, measured from the date of transplant to the date of progression or death.
Secondary objectives:
- Assess minimal residual disease (MRD) rate at 12 months after starting Isatuximab maintenance therapy
- Assess overall best response rate (defined as the occurrence of VGPR or better and CR/sCR) before the 4th Isatuximab cycle, and at 12, 24, and 36 months after starting maintenance therapy
- Assess MRD rate before 4th Isatuximab cycle and at 24 months after starting maintenance therapy
- Assess duration of response (DOR)
- Assess overall survival (OS)
- Assess safety
- Conditions
- Multiple Myeloma
- Being tested
- Isatuximab, lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Also called SAR650984
Given by vein over about 75 minutes
lenalidomideDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT) | Experimental | Both 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 Receives: Drug: Isatuximab; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
17 Aug 202331 Dec 2027
- First posted20 Mar 2023
- Study start17 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Muzzaffar Qazilbash, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776979
- Sponsor's protocol ID
- 2022-0028
- Other IDs
- NCI-2023-02219
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No