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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daratumumab
Lenalidomide
Dexamethasone
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Experimental Arm: Cycle 1-4 All subjects

Experimental Arm: Cycle 5+ Partial Response or Better

Experimental Arm: Cycle 5+ Less than Partial Response

Arm 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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determination of Response Rates
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

Full Information

First Posted
November 12, 2020
Last Updated
July 17, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04635189
Brief Title
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Official Title
A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm: Cycle 1-4 All subjects
Arm Type
Active Comparator
Arm 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
Arm Title
Experimental Arm: Cycle 5+ Partial Response or Better
Arm Type
Experimental
Arm 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
Arm Title
Experimental Arm: Cycle 5+ Less than Partial Response
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex
Intervention Description
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
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Ozurdex
Intervention Description
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Primary Outcome Measure Information:
Title
Daratumumab Related Infusion Reactions
Description
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Determination of Response Rates
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Ellis
Phone
(585)275-2224
Email
Jessica_Ellis@URMC.Rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Nealon
Phone
(585) 275-9475
Email
Maureen_Nealon@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Passero, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Passero
Phone
585-275-5863

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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