Description:
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
Clinical Trials /
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
NCT04635189
Related Conditions:
- Multiple Myeloma
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- 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
Clinical Trial IDs
- ORG STUDY ID: UMMY20033
- NCT ID: NCT04635189
Conditions
- Multiple Myeloma
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Daratumumab | Darzalex | Experimental Arm: Cycle 1-4 All subjects |
| Lenalidomide | Revlimid | Experimental Arm: Cycle 1-4 All subjects |
| Dexamethasone | Ozurdex | Experimental Arm: Cycle 1-4 All subjects |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
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.
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Daratumumab Related Infusion Reactions |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls. |
Secondary Outcome Measures
| Measure: | Determination of Response Rates |
| Time Frame: | 28 days |
| Safety Issue: | |
| 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 |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Rochester |
Last Updated
July 29, 2021
