Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT01029054
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myeloma patients who have not received treatment.
- Detailed Description
During the Phase I portion of this clinical trial, the dose of Revlimid® and carfilzomib will be increased until the best and safest amount (or dose) is identified in combination with standard doses of Revlimid® and dexamethasone. "Investigational" means that the drug combination is still being studied and that research doctors are trying to find out more about it such as the safest dose to use, the side effects it may cause and how effective the Revlimid® and carfilzomib and dexamethasone investigational combination is for treating newly diagnosed multiple myeloma. In this clinical trial we are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.
The drug, carfilzomib, has not yet been approved by the FDA (U.S. Food and Drug Administration). Revlimid® and Dexamethasone have been approved by the FDA. The drugs have not been approved in this combination for use for your type of cancer or any other type of cancer. Carfilzomib is being researched to treat multiple myeloma. Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Revlimid® is currently approved by the US FDA in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.
After the Phase I clinical trial defines the safest doses of Revlimid® and carfilzomib and dexamethasone that can be taken together, the research study will move on to its second portion, a Phase II clinical trial. The Phase II portion of the clinical trial will test the clinical effectiveness of the best dose combination of the three drugs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description carfilzomib, lenalidomide w/dexamethasone carfilzomib, lenalidomide plus dexamethasone Phase I: carfilzomib will be taken with a combination of lenalidomide plus dexamethasone in a series of escalating dosages to determine the maximum tolerated dose level Phase II: carfilzomib will be given at the MTD established in the Phase I portion of the study
- Primary Outcome Measures
Name Time Method The Maximum Tolerated Dose (MTD) of Carfilzomib 6 Months Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.
The Percentage of Patients That Achieve a Response to Treatment 4 Months After Treatment Start The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.
sCR is defined as:
* Negative immunofixation on the serum and urine and
* Disappearance of any soft tissue plasmacytomas and
* \< 5% plasma cells in bone marrow and
* Normal SFLC ratio and
* Absence of clonal cells in bone marrow
VGPR is defined as:
* Serum and urine M-protein detectable by immunofixation but not on electrophoresis or
* ≥ 90% reduction in serum M-component with urine M-component \< 100 mg per 24 hours
PR is defined as:
* ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
* If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required
- Secondary Outcome Measures
Name Time Method The Percentage of Patients Alive Without Progression 12 Months and 24 Months Post Treatment The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.
Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia.
Trial Locations
- Locations (4)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States