Aggressive Smoldering Curative Approach Evaluating Novel Therapies (ASCENT): A Phase 2 Trial of Induction Consolidation and Maintenance in Subjects With High Risk Smoldering Multiple Myeloma (SMM)
Rafat Abonour, MD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
smoldering multiple myeloma,Smoldering Multiple Myeloma
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Age: Between 18 Years - 80 Years
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Gender: All
Inclusion Criteria
High risk smoldering myeloma, which is untreated
Measurable disease
Previously untreated
Negative pregnancy test
Exclusion Criteria
Monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, symptomatic myeloma, or light chain amyloidosis with organ involvement
Diagnosed or treated for another malignancy less than or equal to 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Other concurrent chemotherapy, or any ancillary therapy considered investigational
Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
Known human immunodeficiency virus (HIV) positive
Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products
Known allergies, hypersensitivity, or intolerance to trial drugs