Multiple Myeloma Clinical Trial
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.
Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).
Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.
Diagnosis of multiple myeloma with diagnosis
Must not have received previous therapy for multiple myeloma
Newly diagnosed and not considered candidate for high-dose chemotherapy
Adequate organ system function
A performance status â‰¤ 3
Ability to swallow and retain oral medication
Female subjects of child bearing potential must be surgically sterile, be post-menopausal
A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma
A diagnosis of WaldenstrÃ¶m's disease
Receiving cancer therapy
Radiation therapy within 14 days of enrollment
Major surgery within 2 weeks before enrollment
Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months
Seropositive for hepatitis B, or seropositive for hepatitis C
Ongoing systemic bacterial, fungal or viral infection
Severe and/or uncontrolled medical conditions
Malignancy within 2 years of study enrollment
Women who are pregnant or lactating
Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
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