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

NCT05271630 | Active Not Recruiting

• 1 other identifier: MCC-20816
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression Free Survival (PFS) at 1 Year

  At 1 Years

• Progression Free Survival (PFS) at 2 Years

  At 2 years

• MRD by NGS Clonoseq testing

  At 2 years

Study Arms (2)

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; Drug: Immunomodulatory Agent

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; Drug: Immunomodulatory Agent; Drug: Proteasome Inhibitor

Interventions

Immunomodulatory Agent DRUG

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

Double Maintenance After Autologous Stem Cell Transplant; Single Maintenance After Autologous Stem Cell Transplant

Proteasome Inhibitor DRUG

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

Double Maintenance After Autologous Stem Cell Transplant

Autologous Stem Cell Transplant OTHER

This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT

Double Maintenance After Autologous Stem Cell Transplant; Single Maintenance After Autologous Stem Cell Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Myeloma patients receiving treatment at Moffitt Cancer Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Clinical Trial Search

Biospecimen

Retention: SAMPLES WITH DNA

Minimal Residual Disease (MRD) testing by Clonoseq will be performed in the peripheral blood of the patients at the same time points that MRD testing will be done in the bone marrow in addition to at 6 and 18 months. Investigators will examine the impact gut microbiota on MRD status and racial ethnic differences in study population. Stool samples will be collected at baseline and 1- and 2-years post Autologous Stem Cell Transplant.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Adjuvants, Immunologic; Proteasome Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Study Officials

• Doris Hansen, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: April 20, 2022
• Primary Completion: December 4, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)