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Clinical Trial 20816

Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT05271630

Phase: N/A
Principal Investigator: Hansen, Doris

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Overview

Study Title

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).

Objective

Primary: To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant. Secondary: 1. To determine progression free survival at 1- & 2-years post-transplant and correlate to MRD status. 2. To evaluate MRD by NGS (clonoseq) in peripheral blood of patients and correlate with bone marrow MRD status.

Treatments

Therapies

Bone Marrow Transplant

Medications

Bortezomib (); CC-4047 (Pomalidomide); CC-5013 (Lenalidomide); Ixazomib (); Lenalidomide (Revlimid); PS-341 (Bortezomib); Pomalidomide (); Velcade (Bortezomib); carfilzomib (Kyprolis)

Inclusion Criteria

Inclusion Criteria:

  • All multiple myeloma 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.
  • Other criteria may apply

  • Exclusion Criteria

    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.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.