Status:
ACTIVE_NOT_RECRUITING
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Adaptive Biotechnologies
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT)...
Detailed Description
This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.
Eligibility Criteria
Inclusion
- All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate.
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Histologically confirmed diagnosis of multiple myeloma.
- Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation.
- Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry.
- Measurable disease at diagnosis per IMWG criteria serum M spike ≥ 1g/dL, or Urine M protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/L with an abnormal ratio.
- Patients must have the Clonoseq ID sample showing a trackable clone in bone marrow.
Exclusion
- Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
- Prior evidence of disease progression
- Patients who have other malignancy associated with a high risk of progression in the next 2 years.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05271630
Start Date
April 20 2022
End Date
December 1 2026
Last Update
December 15 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612