This is a phase II interventional study evaluating the use of minimal residual disease by next generation sequencing to defer autologous hematopoietic stem cell transplantation (AHCT) in patients with newly diagnosed multiple myeloma.
This trial is currently open and accepting patients.
While AHCT is an important treatment strategy for patients with multiple myeloma, from a safety standpoint, AHCT is associated with both acute toxicities that reduce quality of life and long-term toxicities that may limit life expectancy for some patients. Additionally its benefit in patients without evidence of minimal residual disease (MRD) is unknown.
We propose to examine MRD response as a strategy to defer AHCT in a systematic manner.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Inclusion Criteria:
Exclusion Criteria:
Phase 2
Enrollment: 40 patients (estimated)
View MoreSeptember 25, 2026
Minimal residual disease (MRD)–guided deferral of autologous stem cell transplantation (ASCT) remained feasible after nearly 4 years of follow-up in the phase 2 MILESTONE study (NCT04991103). Among 20 transplant-eligible patients with newly diagnosed multiple myeloma, 5 achieved MRD negativity following induction and deferred ASCT according to the study protocol. After a median follow-up of about 42.3 months, 2 of these patients had experienced disease progression and none had died.
High-dose therapy followed by ASCT remains an important consolidation strategy for eligible patients with newly diagnosed multiple myeloma. Modern quadruplet regimens have increased the proportion of patients achieving deep responses before transplantation, prompting research into whether upfront ASCT is necessary for every eligible patient.
MILESTONE enrolled 20 patients who received 6 cycles of induction with daratumumab, bortezomib, lenalidomide, and dexamethasone (D-VRd). MRD status after induction determined whether patients proceeded to ASCT or deferred the procedure. Five patients (25%) achieved MRD negativity below the 10-5 threshold and qualified for transplant deferral
View all clinical trial locations sorted by state.
Birmingham, AL
We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.
(888) 828-2206If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.
You can explore trial locations from around the US and connect directly with a trial coordinator.
Find Nearby LocationsYou can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
Still need help? Send us a message