New York Oncology Hematology | Albany, NY
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Multiple myeloma (MM), requiring treatment, defined by any of the following:
Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis
Exposure to any of the following:
Received treatment (chemotherapy, surgery, et cetera [etc]) for a malignancy (other than SMM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion), which is considered cured with minimal risk of recurrence within 3 years
Medical or psychiatric condition or disease (for example, active systemic disease [including presence of auto-antibodies], uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or their excipients, or known sensitivity to mammalian-derived products (including dairy allergy)
Primary purpose
Allocation
Interventional model
Masking
390 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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