Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05344833
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
    Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39.
  • Lenalidomide — DRUG
    Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.

Study Details

This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)

Key Dates

Start date
Jan 5, 2023
Status verified
May 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Isatuximab and Lenalidomide Maintenance
    All participants will receive: Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-21 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.

Primary Outcome Measure

Number of participants that have MRD-negative CR rate, defined as 10-6 [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Sweiss Karen, PharmD
[email protected]
312-996-0875
Marisol Vega, MS
[email protected]
312-355-5035
Huntsman Cancer InstituteSalt Lake CityUtah84112
Douglas Sborov, MD
[email protected]
801.585.3229
Mia Kowalczyk
[email protected]
801.585.0303

Find similar trials in Chicago, IL

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By specialty
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University of Illinois at Chicago· Chicago, ILHuntsman Cancer Institute· Salt Lake City, UT

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