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

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Other: Autologous Stem Cell Transplant; Drug: Immunomodulatory Agent; Drug: Proteasome Inhibitor

• Registration Number: NCT05271630
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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).

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 Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Study Start: 2022-04-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 69

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double Maintenance After Autologous Stem Cell Transplant	Immunomodulatory Agent	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.
Single Maintenance After Autologous Stem Cell Transplant	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
Single Maintenance After Autologous Stem Cell Transplant	Immunomodulatory Agent	Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma
Double Maintenance After Autologous Stem Cell Transplant	Proteasome Inhibitor	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.
Double Maintenance After Autologous Stem Cell Transplant	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States