Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant POST AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

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:

  • 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.

Additional Trial Information

Observational Trial

Enrollment: 69 patients (estimated)

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Trial Locations

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Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting
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