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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271630
• Other study ID #: MCC-20816
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Garrett Welch
• Phone: 813-745-6514
• Email: Garrett.Welch[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Autologous Stem Cell Transplant
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT

Drug:
• 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

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Adaptive Biotechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRD conversion rate	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.	At 1 year after transplant
Secondary	Progression Free Survival (PFS) at 1 Year	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	At 1 Years
Secondary	Progression Free Survival (PFS) 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	At 2 years
Secondary	MRD by NGS Clonoseq testing	MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow	At 2 years

External Links

•   Moffitt Clinical Trial Search