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NCT Number: NCT05271630

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).

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Immunomodulatory Agent

Drug

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

Proteasome Inhibitor

Drug

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

Primary outcomes

  1. MRD conversion rate

    Time frame: 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 outcomes

  1. Progression Free Survival (PFS) at 1 Year

    Time frame: 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

  2. Progression Free Survival (PFS) at 2 Years

    Time frame: 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

  3. MRD by NGS Clonoseq testing

    Time frame: At 2 years

    MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Adaptive Biotechnologies

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 9, 2022
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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