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  • Cancer Type: Malignant Hematology
  • Study Type: Other
  • NCT#: NCT05271630
  • Phase: N/A
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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.

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