NCT05497804

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

REsponse Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma (REACH)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the rate of sustained minimal residual disease (MRD) negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with this treatment approach in subjects with high-risk multiple myeloma (MM). II. To estimate the overall response rate, very good partial response (VGPR) or better rate and complete response (CR) rate at the end of induction, end of consolidation, end of maintenance and at two years after the completion of treatment. III. To estimate the progression-free survival and overall survival rate. CORRELATIVE RESEARCH OBJECTIVES: I. To describe the clonal architecture through a combination of genomic, epigenomic, proteomic and metabolomic studies before and after treatment, in subjects with high-risk MM. II. To describe the bone marrow microenvironment through various stages of treatment and the time of MRD negative state and at time of relapse. OUTLINE: INDUCTION: Patients receive carfilzomib intravenously (IV) on days 1, 2, 8, and 15 of cycle 1 and days 1, 8, and 15 of cycles 2-12, lenalidomide orally (PO) days 1-21 of each cycle, daratumumab subcutaneously (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 SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspirate and biopsy, blood sample collection, echocardiography (ECHO) or multigated acquisition (MUGA) scan, and magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT throughout the study. Patients also undergo chest radiography (x-ray) during screening. After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Conditions

• ISS Stage III Plasma Cell Myeloma
• Multiple Myeloma

Interventions

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

Timeline

• Start date: 2022-09-22
• Primary completion: 2027-11-20
• Completion: 2028-11-20
• First posted: 2022-08-11
• Last updated: 2026-02-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study