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

University of Rochester

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Lenalidomide; Drug: Daratumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04635189

UMMY20033

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 3 patient groups

Experimental Arm: Cycle 1-4 All subjects

Active Comparator group

Description:

Subjects will be treated with the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Treatment:

Drug: Lenalidomide

Drug: Daratumumab

Drug: Dexamethasone

Experimental Arm: Cycle 5+ Partial Response or Better

Experimental group

Description:

Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle

Treatment:

Drug: Lenalidomide

Drug: Daratumumab

Experimental Arm: Cycle 5+ Less than Partial Response

Active Comparator group

Description:

Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Treatment:

Drug: Lenalidomide

Drug: Daratumumab

Drug: Dexamethasone