Multiple Myeloma Clinical Trial
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
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).
Full 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 Criteria:
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 Criteria:
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.
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There is 1 Location for this study
Tampa Florida, 33612, United States More Info
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