Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635189
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Frank Passero, University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Drug: Lenalidomide Drug: Dexamethasone Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Darzalex

Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Name: Revlimid

Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Name: 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 Name: Darzalex

Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Name: 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 Name: Darzalex

Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Name: Revlimid

Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Name: Ozurdex


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635189


Contacts
Layout table for location contacts
Contact: Lisa Metzger (585)276-7078 Lisa_Metzger@URMC.Rochester.edu
Contact: Maureen Nealon (585) 275-9475 Maureen_Nealon@urmc.rochester.edu

Locations
Layout table for location information
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Frank Passero    585-275-5863      
Sponsors and Collaborators
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Frank Passero, MD University of Rochester
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Frank Passero, Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT04635189    
Other Study ID Numbers: UMMY20033
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Lenalidomide
Daratumumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors