Multiple Myeloma Clinical Trial

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

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).

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Full 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.

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Eligibility Criteria

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 is for people with:

Multiple Myeloma

Estimated Enrollment:

69

Study ID:

NCT05271630

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Garret Welch
Contact
813-745-6514
[email protected]
Doris Hansen, MD
Contact
813-745-6162
[email protected]
Melissa Alsina, MD
Sub-Investigator
Rachid Baz, MD
Sub-Investigator
Brandon Blue, MD
Sub-Investigator
Jason Brayer, MD, PhD
Sub-Investigator
Hien D Liu, MD
Sub-Investigator
Jose Ochoa, MD
Sub-Investigator
Taiga Nishihori, MD
Sub-Investigator
Ken Shain, MD, PhD
Sub-Investigator
Omar Castaneda, MD
Sub-Investigator
Ciara Freeman, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

69

Study ID:

NCT05271630

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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