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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Autologous Stem Cell Transplant
* Drug: Immunomodulatory Agent
* Drug: Proteasome Inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Maintenance After Autologous Stem Cell Transplant<br>Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma | Other: Autologous Stem Cell Transplant<br>* This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT<br>Drug: Immunomodulatory Agent<br>* ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant<br>|
| Double Maintenance After Autologous Stem Cell Transplant<br>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. | Other: Autologous Stem Cell Transplant<br>* This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT<br>Drug: Immunomodulatory Agent<br>* ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant<br>Drug: Proteasome Inhibitor<br>* ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |