Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
NCT ID: NCT05271630
Last Updated: 2025-12-15
Study Results
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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ACTIVE_NOT_RECRUITING
69 participants
OBSERVATIONAL
2022-04-20
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT
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.
Autologous Stem Cell Transplant
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior evidence of disease progression
* Patients who have other malignancy associated with a high risk of progression in the next 2 years.
18 Years
ALL
No
Sponsors
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Adaptive Biotechnologies
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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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
Countries
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Related Links
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Moffitt Clinical Trial Search
Other Identifiers
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MCC-20816
Identifier Type: -
Identifier Source: org_study_id
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