Trial Outcomes & Findings for Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma (NCT NCT01484626)
NCT ID: NCT01484626
Last Updated: 2018-07-10
Results Overview
The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
TERMINATED
PHASE1/PHASE2
3 participants
21 days
2018-07-10
Participant Flow
Participants were recruited from May 2011 through April 2014 (36 months) from the Cardinal Bernardin Cancer Center at Loyola University Medical Center
There are no pre-assignment details to report
Participant milestones
| Measure |
Bendamustine
Bendamustine is combined with standard chemotherapy
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bendamustine
n=3 Participants
Bendamustine is combined with standard chemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.
The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
Outcome measures
| Measure |
Bendamustine
n=3 Participants
Bendamustine is combined with standard chemotherapy
|
|---|---|
|
Number of Patients Experiencing a Toxicity
Experienced no toxicities
|
0 Participants
|
|
Number of Patients Experiencing a Toxicity
Experienced at least one toxicity
|
3 Participants
|
Adverse Events
Bendamustine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bendamustine
n=3 participants at risk
Bendamustine is combined with standard chemotherapy
|
|---|---|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath on Exertion
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Gastrointestinal disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Endocrine disorders
Arthritis
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from November 2011 through June 2014 (32 months)
|
Additional Information
Scott Smith, M.D., Ph.D.
Loyola University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place