Phase 2 N=65 Treatment

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT02416206 ↗

Enrolled (actual)

Serious AEs

73.9%

Results posted

May 2023

Primary outcome: Primary: To Estimate the Response at Day 100 Following Transplant (Rate of CR) — 26; 32; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BeEAM (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northside Hospital, Inc.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY To Estimate the Response at Day 100 Following Transplant (Rate of CR)	26; 32; 7	—
SECONDARY Number of Patients With Overall Survival Post-transplant	60	—
SECONDARY Number of Patients With Progression-free Survival	37	—
SECONDARY Number of Patients Who Relapsed After Transplant	28	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02416206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.