Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05271630
Collaborator
Adaptive Biotechnologies (Industry)
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Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Autologous Stem Cell Transplant
  • Drug: Immunomodulatory Agent
  • Drug: Proteasome Inhibitor

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
69 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
Actual Study Start Date :
Feb 25, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Single Maintenance After Autologous Stem Cell Transplant

Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma

Other: Autologous Stem Cell Transplant
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT

Drug: Immunomodulatory Agent
ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant

Double Maintenance After Autologous Stem Cell Transplant

Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.

Other: Autologous Stem Cell Transplant
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT

Drug: Immunomodulatory Agent
ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant

Drug: Proteasome Inhibitor
ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant

Outcome Measures

Primary Outcome Measures

  1. MRD conversion rate [At 1 year after transplant]

    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 Outcome Measures

  1. Progression Free Survival (PFS) at 1 Year [At 1 Years]

    PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval

  2. Progression Free Survival (PFS) at 2 Years [At 2 years]

    PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval

  3. MRD by NGS Clonoseq testing [At 2 years]

    MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • Adaptive Biotechnologies

Investigators

  • Principal Investigator: Doris Hansen, MD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT05271630
Other Study ID Numbers:
  • MCC-20816
First Posted:
Mar 9, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022