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)
4 other identifiers
interventional
17
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2022
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 20, 2028
February 3, 2026
January 1, 2026
5.2 years
August 3, 2022
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of sustained minimal residual disease (MRD) negativity
MRD negative status at any point, with a repeated MRD negative status one year later. All subjects meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable, with the exception of subjects determined to be a major violation.
At 1 year
Secondary Outcomes (4)
Overall response rate (>= confirmed very good partial response ([VGPR])
End of induction, end of consolidation, and every 3 cycles of maintenance, up to two years or 24. One cycle is 28 days. after treatmentmonths
Overall survival
Up to 10 years
Progression-free survival
Up to 10 years
Incidence of adverse events
Up to 30 days after administration of study therapy
Other Outcomes (2)
Clonal architecture before treatment
Before and after treatment, up to two years or 24 months
Bone marrow microenvironment
Before and after treatment, up to two years or 24 months
Study Arms (1)
Treatment (combination chemotherapy)
EXPERIMENTALINDUCTION: 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.
Interventions
Undergo bone marrow aspiration and biopsy
Given PO
Undergo MRI
Undergo PET/CT
Undergo MUGA scan
Given IV/PO
Undergo CT or PET/CT
Given SC
Undergo blood sample collection
Undergo chest x-ray
Eligibility Criteria
You may qualify if:
- Age \>= 18 years and =\< 80 years.
- Patient must have suspected or confirmed newly diagnosed multiple myeloma by International Myeloma Working Group (IMWG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Provide informed written consent.
- Willing to return to enrolling institution for follow-up during the active treatment phase of the trial.
- Willing to provide blood and bone marrow samples for planned research.
- Life expectancy \> 6 months.
- Able to take aspirin (325 mg) daily as prophylactic anticoagulation.
- Note: subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.
- Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum matrix-assisted laser desorption ionization time-of-flight mass-spectrometry \[MASS-FIX\]) at time of diagnosis before induction therapy initiated and available for review to be enrolled. Note: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained
- High risk myeloma, which is untreated, defined as any two of:
- Beta-2 microglobulin \>5.5
- Gain or amplification of chr1q
- del17p or monosomy 17 or TP53 mutation (if known)
- t(4;14) or t(14;16)
- +12 more criteria
You may not qualify if:
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, light chain amyloidosis with organ involvement.
- Diagnosed or treated for another malignancy =\< 1 year prior to pre- registration or previously diagnosed with another malignancy and have any evidence of residual disease.
- NOTE: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease.
- Other concurrent chemotherapy, or any ancillary therapy considered investigational. NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma.
- NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma
- NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
- Peripheral neuropathy \>= grade 3 on clinical examination or grade 2 with pain =\< 30 days prior to registration.
- Major surgery =\< 14 days prior to pre-registration.
- Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure) or known sensitivity to mammalian-derived products. Known allergies, hypersensitivity, or intolerance to trial drugs.
- Inability to comply with protocol/procedures.
- Received prior treatment for multiple myeloma prior to pre-registration. Note: results can still be pending as long as the tests have been performed
- If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic
Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaji K. Kumar, MD
Mayo Clinic in Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 11, 2022
Study Start
September 22, 2022
Primary Completion (Estimated)
November 20, 2027
Study Completion (Estimated)
November 20, 2028
Last Updated
February 3, 2026
Record last verified: 2026-01