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Trial record 20 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT01078441
Recruitment Status : Terminated (The study was closed early due to weak accrual on June 26, 2012.)
First Posted : March 2, 2010
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Refractory Multiple Myeloma
Interventions Drug: liposomal doxorubicin
Drug: bortezomib
Drug: dexamethasone
Drug: cyclophosphamide
Enrollment 2
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description

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 Number of Baseline Participants 2
Hide Baseline Analysis Population Description
All patients enrolled are included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
51
(48 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title One-year Survival in Patients Treated With This Regimen.
Hide Description Proportion of patients who are still alive at 1 year after registration.
Time Frame Assessed at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and treated patients are included in this analysis.
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description:

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 Number of Participants Analyzed 2
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of patients
0.5
(0.03 to 0.97)
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Chemotherapy
Hide Arm/Group Description 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.
All-Cause Mortality
Combination Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Chemotherapy
Affected / at Risk (%)
Total   1/2 (50.00%) 
Investigations   
Lymphocyte count decreased  1  1/2 (50.00%) 
Neutrophil count decreased  1  1/2 (50.00%) 
Platelet count decreased  1  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Chemotherapy
Affected / at Risk (%)
Total   1/2 (50.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/2 (50.00%) 
Gastrointestinal disorders   
Constipation  1  1/2 (50.00%) 
Nausea  1  1/2 (50.00%) 
General disorders   
Chills  1  1/2 (50.00%) 
Edema limbs  1  1/2 (50.00%) 
Investigations   
Lymphocyte count decreased  1  1/2 (50.00%) 
Weight gain  1  1/2 (50.00%) 
Metabolism and nutrition disorders   
Anorexia  1  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/2 (50.00%) 
Nervous system disorders   
Peripheral motor neuropathy  1  1/2 (50.00%) 
Psychiatric disorders   
Insomnia  1  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01078441     History of Changes
Other Study ID Numbers: NCI-2011-02002
NCI-2011-02002 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2A08 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2010
First Posted: March 2, 2010
Results First Submitted: January 5, 2015
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015