Efficacy and Toxicity Study of Pomalidomide and Dexamethasone in Patients Who Have Relapsed After Exposure to Lenalidomide and Bortezomib
Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide will treatment on pomalidomde and dexamethasone.
Baseline, follow-up, survival and toxicity information will be collected.
|Multiple Myeloma Relapse After Use of Lenalidomide and Bortezomib||Drug: Pomalidomide and Dexamethasone||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Prospective Follow-up of Relapse Myeloma Patients After Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone|
- To assess the progression free survival (PFS) for pomalidomide and dexamethasone in patients who have relapsed and are refractory to lenalidomide and have previously been treated with bortezomib [ Time Frame: 2 year ]
- To assess Overall Response Rate (ORR) [ Time Frame: 2 year ]
- To see if addition of cyclophosphamide with induce additional response in patient who do not achieve an minimal response (MR) after 3 months [ Time Frame: 2 year ]
- To assess Overall Survival (OS) [ Time Frame: 5 year ]
- To assess Duration of Response (DOR) [ Time Frame: 2 year ]
- To assess Safety and Tolerability [ Time Frame: 2 year ]
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Pomalidomide and Dexamethasone
PO pomalidomide 4mg from D1-21 and PO dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle.
PO or IV cyclophosphamide 300mg/m2 on D1, 8 and 15 can be added at the discretion of the treating physician to induce added response under the following circumstances: 1) If there is less than a MR after 3 cycles in the absence of disease progression, or 2) If there is disease progression within the first 3 cycles of Pomalidomide and Dexamethasone treatment.
Patients will be assessed every 28 days (+/-10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first).
Drug: Pomalidomide and Dexamethasone
Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle. Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone conducted in compared with placebo and dexamethasone showed that pomalidomide can improve survival of this group of patients.
Pomalidomide is a new immunomodulatory drug which has been shown to be active in myeloma patients who relapse after bortezomib and lenalidomide. A recent phase III study comparing pomalidomide plus dexamethasone with placebo plus high dose dexamethasone in patients with prior exposure to bortezomib and lenalidomide, showed that the use of pomalidomide significantly improve the overall survival of these patients. However, this study did not include Asian patients. Therefore the efficacy and toxicity of pomalidomide remains to be described in Asian patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT02158702
|National University Hospital|
|Singapore, Singapore, 119074|
|Singapore General Hospital|
|Principal Investigator:||Wee Joo Chng, MBBS||National University Hospital, Singapore|