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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05271630
Other study ID # MCC-20816
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2022
Est. completion date February 2025

Study information

Verified date February 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Garrett Welch
Phone 813-745-6514
Email Garrett.Welch@moffitt.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 69
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute Adaptive Biotechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRD conversion rate 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. At 1 year after transplant
Secondary Progression Free Survival (PFS) at 1 Year 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 At 1 Years
Secondary Progression Free Survival (PFS) 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 At 2 years
Secondary MRD by NGS Clonoseq testing MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow At 2 years
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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