Trial Outcomes & Findings for Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant (NCT NCT01078441)
NCT ID: NCT01078441
Last Updated: 2015-01-12
Results Overview
Proportion of patients who are still alive at 1 year after registration.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Assessed at 1 year
Results posted on
2015-01-12
Participant Flow
Two patients were enrolled from ECOG member institutions between September 14, 2010 and June 26, 2012. The study was closed early due to weak accrual.
Participant milestones
| Measure |
Treatment (Combination Chemotherapy)
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Combination Chemotherapy)
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Treatment (Combination Chemotherapy)
n=2 Participants
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 1 yearPopulation: All eligible and treated patients are included in this analysis.
Proportion of patients who are still alive at 1 year after registration.
Outcome measures
| Measure |
Treatment (Combination Chemotherapy)
n=2 Participants
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV
|
|---|---|
|
One-year Survival in Patients Treated With This Regimen.
|
0.5 Proportion of patients
Interval 0.03 to 0.97
|
Adverse Events
Combination Chemotherapy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Chemotherapy
n=2 participants at risk
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Combination Chemotherapy
n=2 participants at risk
Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight gain
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60