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

NCT04635189 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: UMMY20033
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Daratumumab Related Infusion Reactions

  To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.

  28 days

Secondary Outcomes (1)

• Determination of Response Rates

  28 days

Study Arms (3)

Experimental Arm: Cycle 1-4 All subjects

ACTIVE COMPARATOR

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

Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone

Experimental Arm: Cycle 5+ Partial Response or Better

EXPERIMENTAL

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

Drug: Daratumumab; Drug: Lenalidomide

Experimental Arm: Cycle 5+ Less than Partial Response

ACTIVE COMPARATOR

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

Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Daratumumab DRUG

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

Also known as: Darzalex

Experimental Arm: Cycle 1-4 All subjects; Experimental Arm: Cycle 5+ Less than Partial Response; Experimental Arm: Cycle 5+ Partial Response or Better

Lenalidomide DRUG

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

Also known as: Revlimid

Experimental Arm: Cycle 1-4 All subjects; Experimental Arm: Cycle 5+ Less than Partial Response; Experimental Arm: Cycle 5+ Partial Response or Better

Dexamethasone DRUG

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

Also known as: Ozurdex

Experimental Arm: Cycle 1-4 All subjects; Experimental Arm: Cycle 5+ Less than Partial Response

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Frank Passero, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hematology/Oncology

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: July 27, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data for any type of analyses.

Locations

US (1)