Multiple Myeloma
Conditions
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.
Interventions
OTHERAutologous Stem Cell Transplant
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT
DRUGImmunomodulatory Agent
ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant
ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Adaptive Biotechnologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRD conversion rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) at 2 Years | 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 |
| Progression Free Survival (PFS) at 1 Year | 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 |
| MRD by NGS Clonoseq testing | At 2 years | MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDoris Hansen, MD
Moffitt Cancer Center
Outcome results
None listed