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

NCT ID: NCT05271630

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Autologous Stem Cell Transplant

Intervention Type OTHER

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

Immunomodulatory Agent

Intervention Type DRUG

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.

Autologous Stem Cell Transplant

Intervention Type OTHER

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

Immunomodulatory Agent

Intervention Type DRUG

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

Proteasome Inhibitor

Intervention Type DRUG

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

Interventions

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Autologous Stem Cell Transplant

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

Intervention Type OTHER

Immunomodulatory Agent

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

Intervention Type DRUG

Proteasome Inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adaptive Biotechnologies

INDUSTRY

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doris Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MCC-20816

Identifier Type: -

Identifier Source: org_study_id

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