NCT06997081

ERd Combination Treatment in Newly Diagnosed Multiple Myeloma

Elranatamab, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma, a Clinical and Correlative Phase 2 Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	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.
DRUG	Dexamethasone	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.
DRUG	Elranatamab	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.

Timeline

• Start date: 2025-09-16
• Primary completion: 2030-09-30
• Completion: 2030-09-30
• First posted: 2025-05-30
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study