A Phase II Study of Sequential Carfilzomib, Clarithromycin, Lenalidomide, and Dexamethasone (Car-BiRD) Therapy for Subjects with Newly Diagnosed Multiple Myeloma
Study Status
Open to Enrollment
Study Description
The purpose of this study s to determine the safety and effectiveness of the carfilzomib and dexamethasone drug combination given prior to the BiRD regimen (Biaxin, Revlimid and Dexamethasone) in patients newly diagnosed with multiple myeloma.
Although new anti-myeloma therapies have been developed, patients are still not cured of their disease. In a previous research study conducted at Weill Cornell Medical College, newly diagnosed multiple myeloma patients responded well to the BiRD regimen.
The new investigational drug called carfilzomib is a proteasome inhibitor. Proteasomes are found inside all cells. Blocking the action of proteasomes causes cells to die, and cancer cells are more susceptible to this effect than normal cells. The investigators hope that giving carfilzomib and dexamethasone before BIRD will lead to improvement in myeloma reduction.
Treatment Plan:
All patients will begin treatment with Carfilzomib + Dexamethasone. Carfilzomib will be given intravenous at a dose of 45mg/m2 on days 1, 2, 8, 9, 15, 16 for each 28-day cycle. Dexamethasone (Decadron®) will be given orally at a dose of 20 mg on days 1, 2, 8, 9, 15, 16, 22 and 23 for each 28-day cycle.
At the maximum disease response on Carfilzomib + Dexamethasone treatment, patients will then transition to BiRD therapy. BiRD is: Clarithromycin (Biaxin®) orally at a dose of 500 mg twice a day, Dexamethasone (Decadron®) orally at a dose of 40 mg on days 1, 8, 15 and 22, and Lenalidomide (Revlimid®) orally at a dose of 25 mg/day days 1-21 out of a 28-day cycle.
At the maximum disease response on BiRD, patients may then choose either to proceed to autologous stem cell transplant or Lenalidomide (Revlimid®) which will be given as a maintenance medication at a dose of 10 mg/day days 1-21 out of a 28-day cycle. Patients can continue on Lenalidomide maintenance for a maximum of 24 cycles (approximately 2 years).
If there is progression of myeloma at any time, the study medications will end and alternative treatment will be offered.
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Website: http://myelomacenter.org
Blog: http://myelomacenterblog.com
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Disease Status and/or Stage
Newly Diagnosed Multiple Myeloma; No Previous Treatment
Sponsor
Weill Cornell Medical College
Key Eligibility
- Men and women age 18 and older
- Multiple Myeloma
- No previous treatment
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- The Myeloma Center
- (212) 746-3964
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
