RecruitingPhase 2NCT05145400

Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

Phase 2 Study of Isatuximab Plus Lenalidomide and Dexamethasone in Highly Toxicity-vulnerable Subjects With Newly Diagnosed Multiple Myeloma


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

50 participants

Start Date

Feb 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — isatuximab, lenalidomide, and dexamethasone (Isa-Rd) — as a gentler treatment option for frail or very elderly patients with newly diagnosed multiple myeloma, a cancer of plasma cells in the bone marrow. Standard intensive treatments may be too harsh for this group of patients. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You are considered frail, elderly, or not a good candidate for intensive standard treatment due to health conditions or low performance - You have measurable disease confirmed by bone marrow or blood tests - You have not had more than one cycle (28 days) of prior myeloma treatment - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - Your doctor believes you are too frail for any systemic treatment at all - You have active infection requiring antibiotics (within the past 14 days) - You have had a heart attack or severe heart problems within the past 3 months - You have AL amyloidosis (a related but different condition) with significant organ damage - You have HIV or active hepatitis A, B, or C - You are known to be allergic to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

Pharmaceutical form: Solution for infusion Route of administration: Intravenous Isatuximab:10 mg/kg intravenous or 1400 mg subcutaneous (SC) via on-body delivery system (OBDS) will be administered in cycles 1-24.

DRUGLenalidomide

Pharmaceutical form: Capsule for oral use, Route of administration: Oral Lenalidomide capsule will be given oral, the dose will be adjusted according to glomerular filtration rate (GFR): 15 mg daily if GFR \> 60 mL/min, 5 mg daily if GFR 30-60 mL/min, 2.5 mg daily if GFR \< 30 mL/min. Note that dialysis-dependence comprises an exclusion criterion for this study. Lenalidomide will be continued until disease progression, excessive toxicity or death.

DRUGDexamethasone

Pharmaceutical form: Tablet for oral use, Route of administration: Oral Dexamethasone tablet will be given oral: 20 mg given on days 1, 8, 15 and 22 of cycles 1-8. Administration may continue beyond cycle 8, if needed, for the prevention of infusion reactions.


Locations(5)

University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT05145400


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