Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)

Part of paid clinical trials in Miami, Florida.

Sponsor
Carl Ola Landgren, MD, PhD
Study ID
NCT06100237
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
  • Talquetamab — DRUG
    Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.
  • Daratumumab SC — DRUG
    Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.

Study Details

The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.

Key Dates

Start date
Dec 4, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Tec-Dara
    Participants will receive the recommended dosage combination treatment Tec-Dara.
  • Experimental: Cohort B: Tal-Dara
    Dosing and treatment schedule for participants in this group will be determined after Cohort A is completed.

Primary Outcome Measure

Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Michelle Armogan
[email protected]
(305) 243-6578
Carl O Landgren, MD, PhD (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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