Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05497804
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Carfilzomib — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Daratumumab — BIOLOGICAL
    Given SC
  • Dexamethasone — DRUG
    Given IV/PO
  • Lenalidomide — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Chest Radiography — PROCEDURE
    Undergo chest x-ray

Study Details

This phase II trial test whether combination chemotherapy works to improve blood test results in patients with high-risk multiple myeloma. Chemotherapy drugs, such as carfilzomib, daratumumab, lenalidomide, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help determine if patients who have a small amount of cancer left after the initial treatment, called minimal residual disease, will benefit from the drug combination.

Key Dates

Start date
Sep 22, 2022
Status verified
May 2026
Primary completion
Feb 12, 2026
Completion
Sep 4, 2028

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (combination chemotherapy)
    INDUCTION: Patients receive carfilzomib IV on days 2, 8, and 15 of cycle 1 and days 1, 8, and 15 of cycles 2-12, lenalidomide PO days 1-21 of each cycle, daratumumab SC days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive carfilzomib IV on days 1, 8, and 15, lenalidomide PO days 1-21, daratumumab SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive carfilzomib IV on day 1, lenalidomide PO days 1-21, daratumumab day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy, MRI and, CT/PET.

Primary Outcome Measure

Rate of sustained minimal residual disease (MRD) negativity [ Time Frame: At 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo ClinicJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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