High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/12/2018 |
| Start Date: | April 27, 2015 |
| End Date: | May 2020 |
| Contact: | Scott R Solomon, MD |
| Email: | ssolomon@bmtga.com |
| Phone: | 404-255-1930 |
A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the
up-front treatment of patients with multiple myeloma has been associated with improved
disease-free and overall survival in multiple large randomized controlled trials. Following
3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
to single-agent Melphalan with higher toxicity.
up-front treatment of patients with multiple myeloma has been associated with improved
disease-free and overall survival in multiple large randomized controlled trials. Following
3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
to single-agent Melphalan with higher toxicity.
Myeloma patients, following up-front induction therapy, will receive an ASCT following a
high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial
will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as
results from our institution, suggests that following ASCT for the upfront treatment of
myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that
under this protocol, this rate will be at least 65%. Thus we statistically formalize this
study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the
alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with
an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial
will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as
results from our institution, suggests that following ASCT for the upfront treatment of
myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that
under this protocol, this rate will be at least 65%. Thus we statistically formalize this
study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the
alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with
an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
Inclusion Criteria:
- Age between 18 - 70 years
- Karnofsky status ≥ 70%
- Diagnosis of Multiple Myeloma
- Within 9 months of the start of induction chemotherapy and no evidence of relapse or
progression.
- Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least
2x106/kg.
Exclusion Criteria:
- Poor cardiac function: left ventricular ejection fraction <40%
- Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted
- Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary
malignancy), AST/ALT > 3X ULN
- Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min
(calculated creatinine clearance is permitted)
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or
known human immunodeficiency virus (HIV) positive.
- Women of childbearing potential who currently are pregnant or who are not practicing
adequate contraception
- Patients who have any debilitating medical or psychiatric illness which would preclude
their giving informed consent or their receiving optimal treatment and follow-up.
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