Actively Recruiting
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-09-26
50
Participants Needed
5
Research Sites
471 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
G
Genzyme, a Sanofi Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization before study procedures
- Willing and able to follow the study visit schedule and protocol requirements
- Predicted high risk for severe toxicity from standard intensive multiple myeloma treatments
- Frail score of 2 or higher on International Myeloma Working Group instrument, or Karnofsky Performance Status 70 or less, or deemed unsuitable for full-intensity therapy by clinician
- Measurable multiple myeloma diagnosed by standard criteria including bone marrow plasma cells and monoclonal protein levels
- No prior systemic anti-myeloma therapy lasting more than 28 days, with at least 14 days since last therapy
- Radiotherapy allowed during screening if completed at least 14 days before starting study drugs
- Adequate organ function including hemoglobin 8 g/dL or higher, neutrophil count 1.0 x 10^9/L or higher, platelets 30 or 50 x 10^9/L depending on bone marrow plasma cells, and any glomerular filtration rate if not dialysis-dependent
- Females of childbearing potential must have negative pregnancy test and use two methods of birth control as described; males must use condoms and not donate sperm
- Must comply with REVLIMID REMS program requirements
You will not qualify if you...
- Active infection requiring systemic antibiotics or serious infection within 14 days before treatment
- Deemed unsuitable for systemic therapy due to severe comorbidities or frailty
- Clinically significant uncontrolled medical conditions posing excessive risk
- Light-chain (AL) amyloidosis or clinically significant amyloidosis
- Recent myocardial infarction within 3 months, severe heart failure, uncontrolled angina or arrhythmias
- Allergy or intolerance to study medications or their components
- Gastrointestinal diseases interfering with oral drug absorption or tolerance
- Serious medical or psychiatric illness likely to interfere with study participation
- Concurrent investigational agents within 14 days or 5 half-lives before study
- Use of other anti-cancer agents except certain low-risk hormonal therapies
- Known HIV positive or active hepatitis A, B, or C infection, or tuberculosis
- Use of chronic daily corticosteroids exceeding low dose for non-myeloma conditions
- Receiving prohibited medications or treatments that cannot be discontinued or replaced
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Actively Recruiting
5
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Shamina Williams
CONTACT
L
Lori Stravers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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