Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma
The purpose of this study is to evaluate the safety and effectiveness of an investigational new drug called carfilzomib, in combination with dexamethasone in subjects with newly diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) [BiRD] then lenalidomide alone.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sequential Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Newly Diagnosed Multiple Myeloma|
- Response to Car-BiRD treatment. [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]
Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease, Plateau.
- Event free survival [ Time Frame: From date of study enrollment until the date of first documented progression, assessed up to 36 months. ] [ Designated as safety issue: No ]an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, or death.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Car-BiRD Therapy
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles.Drug: Dexamethasone
20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
Other Name: DECADRON®Drug: Clarithromycin
500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Other Name: BiaxinDrug: Lenalidomide
25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Other Name: RevlimidDrug: Dexamethasone
40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.Drug: Lenalidomide
10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
Other Name: Revlimid
While new anti-myeloma therapies such as bortezomib and immunomodulatory drugs have been developed, multiple myeloma remains an incurable malignancy. Given that obtaining a complete remission (CR) with therapy will allow patients with newly diagnosed multiple myeloma to enjoy a higher quality of life and longer duration of freedom from disease symptoms, finding an optimally effective and well-tolerated regimen is imperative.
The robust overall response rate of 91% with the BiRD regimen for patients with newly diagnosed multiple myeloma is encouraging and we believe that by adding carfilzomib the overall response rate and CR rate can be improved. As carfilzomib has proven efficacy in myeloma and in patient's who have relapsed on bortezomib, we anticipate that it will synergize with the previous BiRD regimen to induce greater reduction of tumor burden overall.
The primary endpoints include best response rate, toxicities, progression free survival, event free survival, and overall survival. In those patients who are eligible for autologous stem cell transplantation, we will also study the effect of carfilzomib on CD 34+ stem cell yield following mobilization.
|Contact: Tomer Mark, M.D.||(646) firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicial College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Linda Tegnestam, R.N. 212-746-1480 email@example.com|
|Principal Investigator: Tomer Mark, M.D.|
|Sub-Investigator: Ruben Niesvizky, M.D.|
|Sub-Investigator: Roger Pearse, M.D.|
|Sub-Investigator: Tsiporah Shore, M.D.|
|Principal Investigator:||Tomer Mark, M.D.||Weill Cornell Medicial College|