High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

NCT02416206 | Completed Phase 2 Results

• 1 other identifier: NSH 1107
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• To Estimate the Response at Day 100 Following Transplant (Rate of CR)

  Using IMWG criteria: PR (partial response) noted as \>50% reduction of serum M-protein and reduction in 24hr urinary M-protein by \>90% or to \<200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

  Day 100

Secondary Outcomes (3)

• Number of Patients With Overall Survival Post-transplant

  3 years

• Number of Patients With Progression-free Survival

  3 years

• Number of Patients Who Relapsed After Transplant

  3 years

Study Arms (1)

BeEAM

EXPERIMENTAL

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

Drug: BeEAM

Interventions

BeEAM DRUG

BeEAM

BeEAM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Scott Solomon
• Organization: The Blood and Marrow Transplant Group of Georgia

ssolomon@bmtga.com

404-255-1930

Study Officials

• Scott R Solomon, MD

  Northside Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 14, 2015
• Study Start: April 27, 2015
• Primary Completion: March 26, 2020
• Study Completion: April 21, 2021
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-05

Locations

US (1)