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High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02416206
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : December 14, 2017
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Northside Hospital, Inc.

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
Multiple Myeloma Drug: BeEAM 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Melphalan
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BeEAM
Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma
Drug: BeEAM

Primary Outcome Measures :
  1. To estimate the response at day 100 following transplant (rate of CR) [ Time Frame: Day 100 ]

Secondary Outcome Measures :
  1. Number of patients with overall survival post-transplant [ Time Frame: 1 year ]
  2. Number of patients with event-free survival [ Time Frame: 1 year ]
  3. Number of patients with non-relapse mortality [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416206

Contact: Scott R Solomon, MD 404-255-1930 ssolomon@bmtga.com
Contact: Stacey L Brown, BA 404-851-8238 stacey.brown@northside.com

United States, Georgia
Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott R. Solomon, MD    404-255-1930      
Sponsors and Collaborators
Northside Hospital, Inc.
Teva Pharmaceuticals USA
Principal Investigator: Scott R Solomon, MD Northside Hospital


Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT02416206     History of Changes
Other Study ID Numbers: NSH 1107
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Northside Hospital, Inc.:
Multiple myeloma
hematopoietic stem cell transplant

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs