Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

Sponsor
Stichting European Myeloma Network
Study ID
NCT06183489
Phase
PHASE2
Status
Recruiting
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Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Elranatamab — DRUG
    Elranatamab will be administered via a subcutaneous injection (SC)

Study Details

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Key Dates

Start date
May 14, 2024
Status verified
Oct 2024
Primary completion
Jul 31, 2027
Completion
Jul 31, 2031

Study Design

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

Arms

  • Experimental: Elranatamab
    Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)

Primary Outcome Measure

Complete Remission (CR) rate [ Time Frame: average 24 weeks ]

Central Contacts

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