Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis|
- Partial hematologic response rate [ Time Frame: Up to 2 years ]Only patients who have received at least 2 cycles of therapy are eligible for response assessment. The proportion of patients with PHR two months post-treatment will be estimated, with a 95% exact binomial confidence interval.
- Overall hematologic response rate [ Time Frame: Up to 2 years ]The proportion of response-evaluable patients experiencing OHR will be estimated, with a 95% exact binomial confidence interval.
- Organ response rate [ Time Frame: Up to 2 years ]The proportion of response-evaluable patients experiencing OrRR will be estimated, with a 95% exact binomial confidence interval.
- Time to Treatment Failure [ Time Frame: Up to 2 years ]Time to failure will be assessed for each patient from day of first treatment, where failure will be defined as disease progression or death. The survival function of TTF for response-evaluable patients will be estimated using the product-limit (Kaplan-Meier) estimator, along with 95% confidence bounds. The median time to failure will be estimated from the survival function. The analysis will be repeated on all patients who receive any therapy.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2021|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Subjects with AL will receive Bendamustine and Dexamethasone
Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:
Available to qualifying subjects is the option to dose escalate to dose level (+)1:
Other Names:Drug: Dexamethasone
40 mg orally on days 1, 8, 15, 22 of each cycle
Other Name: Decadron
Systemic light-chain amyloidosis (AL) is a protein conformation disorder due to a clonal plasma cell dyscrasia. There are no established and approved second-line therapies for patients with systemic AL amyloidosis who fail initial melphalan-based treatment, be it high-dose melphalan with stem cell transplant or oral melphalan and dexamethasone (MDex). Therefore new treatments are needed for those who fail initial therapy and for those who initially respond but subsequently relapse.
Therapy of AL is generally based on treatment regimens used in multiple myeloma (MM). Bendamustine achieves partial response with relapsed/refractory MM. Based on this high anti-MM activity, we anticipate that bendamustine will also be very active in clonal plasma cell disorder associated with AL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222260
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10023|
|New York, New York, United States, 10032|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Suzanne Lentzsch, MD, PhD||Columbia University|