Trial Outcomes & Findings for High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma (NCT NCT02416206)

NCT ID: NCT02416206

Last Updated: 2023-05-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: Day 100
• Results posted on: 2023-05-18

Participant Flow

Participant milestones

Measure	BeEAM Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Overall Study STARTED	65
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Baseline characteristics by cohort

Measure	BeEAM n=65 Participants Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Region of Enrollment United States	65 participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 100

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.

Outcome measures

Measure	BeEAM n=65 Participants Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
To Estimate the Response at Day 100 Following Transplant (Rate of CR) Very Good Partial Response (VGPR1)	32 Participants
To Estimate the Response at Day 100 Following Transplant (Rate of CR) Complete Response (CR1)	26 Participants
To Estimate the Response at Day 100 Following Transplant (Rate of CR) Partial Response (PR1)	7 Participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	BeEAM n=65 Participants Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Number of Patients With Overall Survival Post-transplant	60 Participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	BeEAM n=65 Participants Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Number of Patients With Progression-free Survival	37 Participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	BeEAM n=65 Participants Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Number of Patients Who Relapsed After Transplant	28 Participants

Adverse Events

BeEAM

Serious events: 48 serious events

Other events: 17 other events

Deaths: 5 deaths

Serious adverse events

Measure	BeEAM n=65 participants at risk Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Investigations neutropenic fever	47.7% 31/65 • Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months
Gastrointestinal disorders Esophagitis	26.2% 17/65 • Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months

Other adverse events

Measure	BeEAM n=65 participants at risk Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
Cardiac disorders hypertension	21.5% 14/65 • Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months
Nervous system disorders peripheral neuropathy	4.6% 3/65 • Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months

Additional Information

Dr. Scott Solomon

The Blood and Marrow Transplant Group of Georgia

Phone: 404-255-1930

Email: ssolomon@bmtga.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place