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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multiple Myeloma patients receiving treatment at Moffitt Cancer Center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Adaptive Biotechnologies
• Investigators: Principal Investigator: Doris Hansen, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): December 4, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Pharmacologic Actions; Chemical Actions and Uses; Proteasome Inhibitors; Adjuvants, Immunologic
• Other Study ID Numbers: MCC-20816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No