Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Daratumumab; Dexamethasone; Lenalidomide

Criteria

Inclusion Criteria:

• 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 ≤ 3

• Ability to swallow and retain oral medication

• Female subjects of child bearing potential must be surgically sterile, be post-menopausal

Exclusion Criteria:

• A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma

• A diagnosis of Waldenström'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.