Trial Outcomes & Findings for Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma (NCT NCT02037256)

NCT ID: NCT02037256

Last Updated: 2021-05-10

Results Overview

Participants with \>= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2021-05-10

Participant Flow

Participant milestones

Measure	A. Standard of Care Mobilization GROUP A: Standard of care mobiliation: Bortezomib (1.3 mg/m2) in the evening after completion of mobilization with G-CSF	GROUP B: Alternative Mobilization GROUP B: Bortezomib (1.3 mg/m2) IV on days 4 and 7 (if needed)
Overall Study STARTED	3	20
Overall Study COMPLETED	3	17
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	A. Standard of Care Mobilization GROUP A: Standard of care mobiliation: Bortezomib (1.3 mg/m2) in the evening after completion of mobilization with G-CSF	GROUP B: Alternative Mobilization GROUP B: Bortezomib (1.3 mg/m2) IV on days 4 and 7 (if needed)
Overall Study Protocol Violation	0	1
Overall Study Withdrawn prior to Velcade	0	2

Baseline Characteristics

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma

Baseline characteristics by cohort

Measure	Arm A n=3 Participants Pts. receive filgrastim SC on days 1-9 \& begin apheresis on day 5. Pts. undergo apheresis for up to 2 days, \& receive bortezomib intravenously (IV) over 3-5 seconds after target collection is obtained with filgrastim alone or on the 1st day of collection with the Bortezomib plus filgrastim mobilization, prior to receiving the administration of filgrastim. 2nd apheresis will continue until target stem cell dose is reached or for maximum 4 days. Pts. undergo autologous hematopoietic stem cell transplantation after receiving high dose chemotherapy \& peripheral blood stem cell (PBSC) infusion following standard of care procedures. bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under	Arm B n=17 Participants Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8	Total n=20 Participants Total of all reporting groups
Age, Categorical g · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical g · Between 18 and 65 years	2 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical g · >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants	56 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Evaluable patients

Participants with >= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection

Outcome measures

Measure	Group A: Bortezomib 1.3 mg/m2 n=3 Participants Group A: Bortezomib 1.3 mg/m2 in the evening after completion of 5 day mobilization with G-CSF	Group B Bortezomib 1/3 mg/m2 n=17 Participants Group B Bortezomib 1/3 mg/m2 on day 4 of 5 day GCSF mobilizati
>= 2 Fold Increase in Circulating PBSC's Doubling	0 Participants	4 Participants
>= 2 Fold Increase in Circulating PBSC's Less than doubling	3 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: Evaluable patients

Estimated Median Time to Neutrophil Engraftment, ANC 500

Outcome measures

Measure	Group A: Bortezomib 1.3 mg/m2 n=3 Participants Group A: Bortezomib 1.3 mg/m2 in the evening after completion of 5 day mobilization with G-CSF	Group B Bortezomib 1/3 mg/m2 n=17 Participants Group B Bortezomib 1/3 mg/m2 on day 4 of 5 day GCSF mobilizati
Time to Neutrophil Engraftment	12 days to ANC 500 Interval 12.0 to Two few observations to calculate upper limit	13 days to ANC 500 Interval 12.0 to 14.0

Adverse Events

A Treatment (Bortezomib and Filgrastim)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

B Treatment (Bortezomib and Filgrastim)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A Treatment (Bortezomib and Filgrastim) n=6 participants at risk GROUP A Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8 bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under	B Treatment (Bortezomib and Filgrastim) n=17 participants at risk Group B Pts receive filgrastim SC on days 1-8 and receive bortezomib IV over 3-5 seconds on days 4 and day 7 before administraioin of filgrastim. Pts undergo apheresis on days 5-8.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • 6 months	0.00% 0/17 • 6 months
Cardiac disorders Tachycardia	16.7% 1/6 • Number of events 1 • 6 months	0.00% 0/17 • 6 months
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • 6 months	11.8% 2/17 • Number of events 2 • 6 months
Cardiac disorders Hypertensive crisis	0.00% 0/6 • 6 months	5.9% 1/17 • Number of events 1 • 6 months
Immune system disorders Mucositis	0.00% 0/6 • 6 months	5.9% 1/17 • Number of events 1 • 6 months
Gastrointestinal disorders Vomiting	0.00% 0/6 • 6 months	5.9% 1/17 • Number of events 1 • 6 months
Blood and lymphatic system disorders Hypocalcemia	33.3% 2/6 • Number of events 2 • 6 months	17.6% 3/17 • Number of events 3 • 6 months
Blood and lymphatic system disorders Hyperuricemia	16.7% 1/6 • Number of events 1 • 6 months	0.00% 0/17 • 6 months
Blood and lymphatic system disorders Low ionized calcioum	0.00% 0/6 • 6 months	5.9% 1/17 • Number of events 1 • 6 months
Blood and lymphatic system disorders Hypokalemia	0.00% 0/6 • 6 months	17.6% 3/17 • Number of events 3 • 6 months
Infections and infestations Infection 1	16.7% 1/6 • Number of events 1 • 6 months	23.5% 4/17 • Number of events 4 • 6 months
Infections and infestations Infection 2	0.00% 0/6 • 6 months	17.6% 3/17 • Number of events 3 • 6 months

Additional Information

Dr. Divaya Bhutani

Barbara Ann Karmanos Cancer Institute

Phone: 501-680-9229

Email: db3203@cumc.columbia.edu

Results disclosure agreements

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