Overview

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.