Clinical trial NCT05271630: Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
Official title: Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Adaptive Biotechnologies
First posted: 2022-03-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Myeloma patients receiving treatment at Moffitt Cancer Center

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).

Detailed 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.

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.

Primary outcomes:
measure: MRD conversion rate
timeFrame: At 1 year after transplant
Secondary outcomes:
measure: Progression Free Survival (PFS) at 1 Year
timeFrame: At 1 Years
measure: Progression Free Survival (PFS) at 2 Years
timeFrame: At 2 years
measure: MRD by NGS Clonoseq testing
timeFrame: At 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Doris Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: