Clinical Trial 20816
- Cancer Type: Malignant Hematology
- Study Type: Other
- NCT#: NCT05271630
- Phase: N/A
- Principal Investigator: Hansen, Doris
- 813-745-6100
- Or 1-800-679-0775
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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.
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Treatments
Therapies:
Bone Marrow Transplant
Medications:
Bortezomib (); CC-4047 (Pomalidomide); CC-5013 (Lenalidomide); Ixazomib (); Lenalidomide (Revlimid); PS-341 (Bortezomib); Pomalidomide (); Velcade (Bortezomib); carfilzomib (Kyprolis)
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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
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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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