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

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Multiple Myeloma

Treatments: Other: Autologous Stem Cell Transplant; Drug: Immunomodulatory Agent; Drug: Proteasome Inhibitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05271630

MCC-20816

Details and patient eligibility

About

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).

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

69 participants in 2 patient groups

Single Maintenance After Autologous Stem Cell Transplant

Description:

Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma

Treatment:

Drug: Immunomodulatory Agent

Other: Autologous Stem Cell Transplant

Double Maintenance After Autologous Stem Cell Transplant

Description:

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.

Treatment:

Drug: Proteasome Inhibitor

Drug: Immunomodulatory Agent

Other: Autologous Stem Cell Transplant