Trial Outcomes & Findings for Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma (NCT NCT00084747)

Last Updated: 2020-08-17

Results Overview

Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (\~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

signed consent to progression or end of trial. Up to 5 years.

Results posted on

2020-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bortezomib bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
Overall Study STARTED	30
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Bortezomib bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
Overall Study Relapsed	8
Overall Study Death	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib n=30 Participants bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: signed consent to progression or end of trial. Up to 5 years.

Outcome measures

Outcome measures
Measure	Bortezomib n=30 Participants autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
Progression-free Survival	29 months Interval 18.0 to 45.0

SECONDARY outcome

Timeframe: up to 5 years from time of consent

Outcome measures

Outcome measures
Measure	Bortezomib n=30 Participants autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
Overall Survival	55 months Interval 16.0 to 86.0

Adverse Events

Bortezomib

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bortezomib n=30 participants at risk bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
General disorders Nausea/Dehydration	3.3% 1/30 • Number of events 2 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.3% 1/30 • Number of events 2 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.

Other adverse events

Other adverse events
Measure	Bortezomib n=30 participants at risk bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
General disorders Fatigue	63.3% 19/30 • Number of events 19 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Infections and infestations Fever	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Anorexia	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Gastrointestinal disorders Dyspepsia	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders nausea/vomiting	30.0% 9/30 • Number of events 9 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Gastrointestinal disorders Diarrhea	23.3% 7/30 • Number of events 7 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Gastrointestinal disorders Constipation	10.0% 3/30 • Number of events 3 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Infections and infestations Cough	13.3% 4/30 • Number of events 4 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Infections and infestations Upper Respiratory Infection	6.7% 2/30 • Number of events 2 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Neuropathy	36.7% 11/30 • Number of events 11 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Pain	56.7% 17/30 • Number of events 17 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Peripheral Edema	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Immune system disorders Herpes Zoster Reactivation	23.3% 7/30 • Number of events 7 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Rash	6.7% 2/30 • Number of events 2 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Neutrophils	20.0% 6/30 • Number of events 6 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Platelets	33.3% 10/30 • Number of events 10 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Infections and infestations Transaminits 2/2 Hep A from contaminated food	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
General disorders Right extremity swelling, with no DVT	3.3% 1/30 • Number of events 1 • Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.

Additional Information

Dr. Gary Schiller

UCLA

Phone: 310-206-5755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place