Trial Outcomes & Findings for Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant (NCT NCT00839956)

Last Updated: 2017-05-09

Results Overview

The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

The first three months of therapy

Results posted on

2017-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Bortezomib and Vorinostat) Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Overall Study STARTED	31
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Bortezomib and Vorinostat) Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	6
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Bortezomib and Vorinostat) n=31 Participants Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: The first three months of therapy

Population: No patients met stopping rules for significant toxicity in the first three months of therapy.

Outcome measures

Outcome measures
Measure	Arm I (Bortezomib and Vorinostat) n=31 Participants Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: One subject withdrew from the study within first week of study therapy and changed to different therapy and is not included in this outcome measure.

Patients will be followed for initial response to therapy and for progression of disease. Response criteria will be scored according to International Myeloma Working Group uniform response criteria.

Outcome measures

Outcome measures
Measure	Arm I (Bortezomib and Vorinostat) n=30 Participants Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Time to Disease Progression in Patients Who Progressed	2.1 years Interval 0.33 to 5.3

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Arm I (Bortezomib and Vorinostat) n=30 Participants Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Survival for All Patients	25 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Arm I (Bortezomib and Vorinostat) n=30 Participants Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Median Follow-up Survival for All Patients	5.15 years Interval 3.4 to 6.5

Adverse Events

Arm I (Bortezomib and Vorinostat)

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Bortezomib and Vorinostat) n=30 participants at risk；n=31 participants at risk Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Infections and infestations Influenza A Infection	3.2% 1/31 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
Investigations Elevated Creatinine Kinase Levels	3.2% 1/31 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
Immune system disorders Anaphylactic reaction	3.2% 1/31 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.

Other adverse events

Other adverse events
Measure	Arm I (Bortezomib and Vorinostat) n=30 participants at risk；n=31 participants at risk Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Vorinostat: Given PO
Investigations Neutrophil count decreased	30.0% 9/30 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
Gastrointestinal disorders Diarrhea	6.7% 2/30 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
General disorders Fatigue	13.3% 4/30 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
Investigations Platelet count decreased	13.3% 4/30 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.
Gastrointestinal disorders Nausea	6.7% 2/30 • Any adverse event that occurs within 30 days of study treatment Adverse events grades 3 or higher evaluated.

Additional Information

Dr. Leona A. Holmberg

Fred Hutchinson Cancer Research Center

Phone: 206-667-6447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place