This study is being done to answer the following question:
Can minimal residual disease (MRD) help us identify patients more likely to be helped from adding another drug to the usual treatment with three drugs?
Studies suggest that using four drugs together eliminates more of the cancer. However, we do not know if all patients benefit from adding the fourth drug or if adding the fourth drug benefits only patients who have some remaining tumor (or MRD).
We are doing this study because we want to find out if this approach is better or worse than the usual approach for multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
What is the usual approach to multiple myeloma?
The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is treatment with a three-drug regimen: lenalidomide and dexamethasone in combination with bortezomib or daratumumab-hyaluronidase. The three-drug combination of daratumumab-hyaluronidase, lenalidomide, and dexamethasone is approved by the Food and Drug Administration (FDA). This trial will help determine if adding Bortezomib to the three drug combination is beneficial.
This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI). The trial will be led by the ECOG-ACRIN Medical Group, with the participation of the network of NCTN organizations: NRG Oncology; the Alliance for Clinical Trials in Oncology; and SWOG.
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital
Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042
- 18 years of age or older
- Participant must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of treatment
- Participant must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later
- Additional eligibility in protocol
- Peripheral neuropathy ≥ Grade 2
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
- Additional ineligibility in protocol
For additional information, please see: https://www.clinicaltrials.gov/ct2/show/NCT04566328