Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

Multiple Myeloma Clinical Trial

— Bortezomib  

Official title:

Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01328236
• Other study ID #: 26866138CAN2026
• Status: Recruiting
• Phase: Phase 2
• First received: March 29, 2011
• Last updated: September 21, 2011
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2011
• Source: Clinical Service, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).

Description:

Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

Other known NCT identifiers

• NCT01327716

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib

• KPS = 60

• Adequate liver and renal function within 2 weeks of Screening:

• Bilirubin = 1.5 × the upper limit of normal (ULN)

• Alanine aminotransferase (ALT) = 2.5 × the upper limit of normal (ULN)

• Aspartate aminotransferase (AST) = 2.5 × the upper limit of normal (ULN)

• Cardiac function > ? grade and ejection fraction > 45%

• Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care

Exclusion Criteria:

• has taken Bortezomib

• KPS = 60 scores

• mental illness

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Plasma Cell
• Multiple Myeloma
• Plasma Cell Leukemia

Intervention

Drug:
• Bortezomib
INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1, 4, 8, 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1, 4, 8, 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
• Liposome doxorubicin
INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
• Dexamethasone
INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
China	Beijing Clinical Service Center	Beijing	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Clinical Service, China	Affiliated Hospital to Academy of Military Medical Sciences, Beijing Chao Yang Hospital, Chinese PLA General Hospital, Harbin Institute of Hematology and Oncology, Henan Provincial Hospital, Peking University Third Hospital, Shanghai Changzheng Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria	Day 1 of every treatment cycle	No
Secondary	the rate of response	The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.	Day 1 of every treatment cycle	No
Secondary	partial remission rate	The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.	Day 1 of every treatment cycle	No
Secondary	duration of response		up to 6 months	No
Secondary	overall survival		up to two and a half year	No
Secondary	Adverse Events	Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.	up to two and a half years	Yes
Secondary	FACT/GOC-Ntx		Day 1 of every treatment cycle	Yes