RecruitingMultiple MyelomaCancer
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: UNC Lineberger Comprehensive Cancer Center
You may qualify if…
- ✓ 1. Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- ✓ 2. Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator or protocol designee.
- ✓ 3. Predicted high risk for severe toxicity from intensive induction regimens, such as standard (full-dose) Bortezomib, cyclophosphamide, dexamethasone (VCD), lenalidomide, bortezomib, and dexamethasone (RVD), or lenalidomide and weekly dexamethasone (Rd) as each regimen was published. (Such regimens often use, for example, twice-weekly bortezomib or lenalidomide at 25 mg.) High-risk is defined as one of the following:
- ✓ 1. Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. \[Blood 2015\]),
- ✓ 2. Karnofsky Performance Status (KPS) ≤ 70,
- ✓ 3. Felt not to be candidate for full-intensity induction by treating clinician due to comorbidities, performance status, or other factors not otherwise captured by the Palumbo system or performance status. The reason for the subject's non-candidacy for full-intensity therapy should be described in the clinical documentation.
- ✓ Subjects qualifying for enrollment by criterion C should be discussed with the Medical Monitor before enrollment, to ensure uniform application of this criterion across participating sites.
- ✓ 4. Measurable MM diagnosed according to the following standard criteria. Criteria A and B must be met, in addition to C and/or D:
You may not qualify if…
- ✕ 1. Active infection requiring systemic antibiotics or other serious infection within 14 days prior to study treatment.
- ✕ 2. Subjects felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status, or other severe limitations. Such limitations can be conceptualized generally as making subjects exceedingly high-risk for any systemic treatment for their MM. These limitations often stem from medical comorbidities unrelated to MM and they are hence unlikely to improve with MM therapy. The reasons for exclusion will be documented.
- ✕ 3. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the subject or may interfere with compliance or interpretation of the study results.
- ✕ 4. Light-chain (AL) amyloidosis. Subjects with secondary amyloidosis due to MM are eligible, if the amyloidosis is not felt to be a clinically significant issue (e.g., amyloid found incidentally on bone marrow core biopsy without evidence of amyloid-mediated organ compromise).
- ✕ 5. Myocardial infarction within 3 months prior to study treatment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- ✕ 6. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- ✕ 7. 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 therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- ✕ 8. Known gastrointestinal (GI) disease that could interfere with the oral absorption or tolerance of dexamethasone or lenalidomide including difficulty swallowing.
Where it's recruiting
North Carolina
Chapel Hill · Charlotte · Durham · Wilmington
Ohio
Columbus
Source: ClinicalTrials.gov · NCT05145400 · last updated 2026-06-02