Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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
Arms and Interventions
| 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:
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Names:
|
| 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:
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
|
| 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:
Drug: Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Other Names:
Drug: Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Daratumumab Related Infusion Reactions [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
- Determination of Response Rates [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
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
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A diagnosis of Waldenström's disease
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
Investigators
- Principal Investigator: Frank Passero, MD, University of Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMMY20033