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

July 17, 2023 updated by: Frank Passero, University of Rochester

A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
          • Frank Passero
          • Phone Number: 585-275-5863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Daratumumab
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Other Names:
  • Darzalex
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
  • Revlimid
Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Names:
  • Ozurdex
Experimental: 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
Drug: Daratumumab
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Other Names:
  • Darzalex
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
  • Revlimid
Active Comparator: 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
Drug: Daratumumab
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Other Names:
  • Darzalex
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
  • Revlimid
Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Names:
  • Ozurdex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daratumumab Related Infusion Reactions
Time Frame: 28 days
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Response Rates
Time Frame: 28 days
To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Frank Passero, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMMY20033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data collected during the trial will be shared after deidentification, including dictionaries.

IPD Sharing Time Frame

Data will be available immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data for any type of analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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