Trial Outcomes & Findings for Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01351623)
NCT ID: NCT01351623
Last Updated: 2017-04-13
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
2 years
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Carfilzomib
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Carfilzomib
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Carfilzomib
n=44 Participants
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Outcome measures
| Measure |
Carfilzomib
n=35 Participants
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
To Evaluate the Best Overall Response Rate (ORR)
Complete Response/CR
|
1 Participants
|
|
To Evaluate the Best Overall Response Rate (ORR)
Partial Response/PR
|
9 Participants
|
|
To Evaluate the Best Overall Response Rate (ORR)
Minimal Response/MR
|
3 Participants
|
|
To Evaluate the Best Overall Response Rate (ORR)
Stable Disease/SD
|
2 Participants
|
|
To Evaluate the Best Overall Response Rate (ORR)
Progressin of Disease/POD
|
12 Participants
|
|
To Evaluate the Best Overall Response Rate (ORR)
Very Good Partial Response/PR
|
8 Participants
|
Adverse Events
Carfilzomib
Serious events: 28 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carfilzomib
n=44 participants at risk
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
Infections and infestations
Abdominal Infection
|
2.3%
1/44
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
4/44
|
|
Blood and lymphatic system disorders
Anemia
|
6.8%
3/44
|
|
Gastrointestinal disorders
Appendicitis
|
2.3%
1/44
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, spec
|
4.5%
2/44
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.3%
1/44
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/44
|
|
Psychiatric disorders
Confusion
|
2.3%
1/44
|
|
Blood and lymphatic system disorders
Death NOS
|
9.1%
4/44
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
5/44
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
2/44
|
|
Cardiac disorders
Heart failure
|
6.8%
3/44
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
4.5%
2/44
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
4.5%
2/44
|
|
Cardiac disorders
Hypertension
|
9.1%
4/44
|
|
Cardiac disorders
Hypotension
|
4.5%
2/44
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
2/44
|
|
Infections and infestations
Infections and infestations - Other
|
6.8%
3/44
|
|
Blood and lymphatic system disorders
Intracranial hemorrhage
|
2.3%
1/44
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
13.6%
6/44
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
2.3%
1/44
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
11.4%
5/44
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.1%
4/44
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.8%
3/44
|
|
Infections and infestations
Sepsis
|
4.5%
2/44
|
|
Infections and infestations
Upper respiratory infection
|
4.5%
2/44
|
Other adverse events
| Measure |
Carfilzomib
n=44 participants at risk
A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
65.9%
29/44
|
|
General disorders
Nausea
|
59.1%
26/44
|
|
General disorders
Fatigue
|
54.5%
24/44
|
|
General disorders
Headache
|
52.3%
23/44
|
|
Gastrointestinal disorders
Constipation
|
50.0%
22/44
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
40.9%
18/44
|
|
Cardiac disorders
Peripheral edema
|
38.6%
17/44
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.4%
16/44
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.4%
16/44
|
|
General disorders
Arthralgia
|
36.4%
16/44
|
|
Cardiac disorders
Hypertension
|
27.3%
12/44
|
|
Cardiac disorders
Heart failure
|
25.0%
11/44
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
22/44
|
|
Blood and lymphatic system disorders
Leukopenia
|
43.2%
19/44
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.6%
17/44
|
|
Blood and lymphatic system disorders
Anemia
|
36.4%
16/44
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.7%
10/44
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
18.2%
8/44
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
15.9%
7/44
|
|
Blood and lymphatic system disorders
Hyponatremia
|
11.4%
5/44
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
11.4%
5/44
|
|
Hepatobiliary disorders
ALT increased
|
6.8%
3/44
|
|
Hepatobiliary disorders
AST increased
|
6.8%
3/44
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.8%
3/44
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place