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High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Sponsor
Northside Hospital, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT02416206
Collaborator
Teva Pharmaceuticals USA (Industry)
65
Enrollment
1
Location
1
Arm
71.8
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma
Actual Study Start Date :
Apr 27, 2015
Actual Primary Completion Date :
Mar 26, 2020
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BeEAM

Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma

Drug: BeEAM
BeEAM

Outcome Measures

Primary Outcome Measures

  1. To estimate the response at day 100 following transplant (rate of CR) [Day 100]

Secondary Outcome Measures

  1. Number of patients with overall survival post-transplant [1 year]

  2. Number of patients with event-free survival [1 year]

  3. Number of patients with non-relapse mortality [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blood and Marrow Transplant Group of Georgia Atlanta Georgia United States 30342

Sponsors and Collaborators

  • Northside Hospital, Inc.
  • Teva Pharmaceuticals USA

Investigators

  • Principal Investigator: Scott R Solomon, MD, Northside Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT02416206
Other Study ID Numbers:
  • NSH 1107
First Posted:
Apr 14, 2015
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Northside Hospital, Inc.
Multiple myeloma
hematopoietic stem cell transplant
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Apr 5, 2022