High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

NCT ID: NCT02416206

Last Updated: 2023-05-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-27

Study Completion Date

2021-04-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BeEAM

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

Group Type EXPERIMENTAL

BeEAM

Intervention Type DRUG

BeEAM

Interventions

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BeEAM

BeEAM

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

Northside Hospital, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott R Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Northside Hospital

Locations

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Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NSH 1107

Identifier Type: -

Identifier Source: org_study_id

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