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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05145400
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab — DRUG
    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.
  • Lenalidomide — DRUG
    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.
  • Dexamethasone — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 18, 2022
Status verified
May 2026
Primary completion
May 28, 2033
Completion
May 28, 2033

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    All subjects will receive the same treatment on the study, consisting of isatuximab, lenalidomide, and dexamethasone with 28 days cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From Day 1 of study treatment up to 60 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Jana Hall
[email protected]
919-843-3550
Lynn Ruffin
[email protected]
919-843-7130
Sascha A Tuchman, MD (PRINCIPAL_INVESTIGATOR)
Levine Cancer InstituteCharlotteNorth Carolina28204
Reed Friend, MD (PRINCIPAL_INVESTIGATOR)
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710
Jennifer Tichon, BSN
[email protected]
919-660-7262
Samantha Soares, BSN
[email protected]
(919) 660-6319
Christina Costa, DO (PRINCIPAL_INVESTIGATOR)
Novant Health New Hanover Regional Medical CenterWilmingtonNorth Carolina28401
Helen Walton, RN
[email protected]
910-667-7677
Swaleh Bahamadi, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Golda Danquah
[email protected]
Srinivas Devarakonda, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center· Chapel Hill, NCLevine Cancer Institute· Charlotte, NCDuke Comprehensive Cancer Center· Durham, NCNovant Health New Hanover Regional Medical Center· Wilmington, NCThe Ohio State University Comprehensive Cancer Center· Columbus, OH

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