Trial Outcomes & Findings for Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia (NCT NCT01536067)
NCT ID: NCT01536067
Last Updated: 2016-06-10
Results Overview
Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Every 28 days
Results posted on
2016-06-10
Participant Flow
Participant milestones
| Measure |
Treatment (Monoclonal Antibody Therapy)
INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Monoclonal Antibody Therapy)
INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=3 Participants
INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 28 daysPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 28 daysPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 28 daysPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 28 daysPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to disease progression, assessed up to 12 monthsPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 monthsPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the observation of a response to the time of disease progression, assessed up to 12 monthsPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 30 days for 2 monthsPopulation: All treated and eligible patients
Maximum grade per participant of any AE.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=3 Participants
INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0
Grade 3
|
3 participants
|
|
Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0
Grade 1
|
0 participants
|
|
Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0
Grade 2
|
0 participants
|
Adverse Events
Treatment (Monoclonal Antibody Therapy)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=3 participants at risk
INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Iritis
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Infusion site rash
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Injection site erythema
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Injection site joint redness
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Furuncle
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
66.7%
2/3 • Number of events 5
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve palsy
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Sensory loss
|
33.3%
1/3 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal swelling
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 2
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place