Clinical trial NCT04635189: Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Official title: A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Daratumumab Related Infusion Reactions
timeFrame: 28 days
Secondary outcomes:
measure: Determination of Response Rates
timeFrame: 28 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Frank Passero, MD
role: PRINCIPAL_INVESTIGATOR
References: