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New treatment option for Multiple Myeloma
Official title Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT05776979
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as SAR650984.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 72
You may be able to join if
- Adult patients 18 to 72 years old, with newly diagnosed symptomatic (according to the revised 2014 IMWG criteria as summarized in Appendix A)...
- 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
- people must have high-risk myeloma defined as followed:
You likely can't join 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...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs. Hypersensitivity or...
- 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...
See the full eligibility criteria
- 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...
- 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
- people 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...
- 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...
- 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...
- 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...
- 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...
- Major surgery within 4 weeks before initiating study treatment.
- HIV-positive patients and/or active hepatitis A, B or C infections.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.