IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Miami, Florida.

Sponsor
Dickran Kazandjian, MD
Study ID
NCT06376526
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Linvoseltamab — BIOLOGICAL
    Participants will be administered Linvoseltamab intravenously (IV), using a step-up dosing schedule as follows: * Cycle 1, Day 1: 5mg * Cycle 1, Day 8: 25mg * Cycle 1, Days 15 and 22: 200mg * Cycles 2 and 3, Days 1, 8, 15 and 22: 200mg * Cycle 4, Days 1 and 15: 200mg. For participants who are MRD-positive after four (4) cycles of study treatment: * Cycles 5 and 6, Days 1 and 15: 200 mg

Study Details

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.

Key Dates

Start date
Aug 21, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Linvoseltamab Group
    Participants in this group will be administered a fixed duration of Linvoseltamab for four to six 28-day cycles, depending on minimal residual disease (MRD) conversion status. After four cycles, participants that are MRD-negative will no longer receive study treatment. Participants that are MRD-positive will receive an additional two cycles of Linvoseltamab. Total participation duration is up to 3 years.

Primary Outcome Measure

Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Dickran Kazandjian, MD
[email protected]
305-243-5001
Dickran Kazandjian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Miami· Miami, FL

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