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

NCT ID: NCT04635189

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2026-07-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm: Cycle 1-4 All subjects

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

Group Type: ACTIVE_COMPARATOR

Daratumumab

Intervention Type: DRUG

Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks

Lenalidomide

Intervention Type: DRUG

Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Experimental Arm: Cycle 5+ Partial Response or Better

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

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: DRUG

Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks

Lenalidomide

Intervention Type: DRUG

Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle

Experimental Arm: Cycle 5+ Less than Partial Response

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

Group Type: ACTIVE_COMPARATOR

Daratumumab

Intervention Type: DRUG

Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks

Lenalidomide

Intervention Type: DRUG

Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Interventions

Daratumumab

Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks

Intervention Type: DRUG

Lenalidomide

Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Intervention Type: DRUG

Other Intervention Names

Darzalex; Revlimid; Ozurdex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Frank Passero

Professor of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Passero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

UMMY20033

Identifier Type: -

Identifier Source: org_study_id