ERd Combination Treatment in Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06997081
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Participants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles.
  • Dexamethasone — DRUG
    Participants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6.
  • Elranatamab — DRUG
    Participants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles.

Study Details

The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.

Key Dates

Start date
Sep 16, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

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

Arms

  • Experimental: Elranatamab in combination with lenalidomide and dexamethasone (ERd)
    Participants in this group will receive standard of care (SOC) therapy with ERd combination treatment. Total participation duration is up to 2.5 years.

Primary Outcome Measure

Minimal residual disease (MRD) (10^-5 sensitivity) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Carl Landgren, MD
[email protected]
3052436578
Dickran Kazandijan, MD
[email protected]
3052435001
Carl O Landgren, MD (PRINCIPAL_INVESTIGATOR)
Dickran Kazandijan, MD (PRINCIPAL_INVESTIGATOR)

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By specialty
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By research site
University of Miami· Miami, FL

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