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

Phase 2

• Conditions: Plasma Cell Leukemia; Multiple Myeloma
• Interventions: Drug: Bortezomib; Drug: Liposome doxorubicin; Drug: Dexamethasone

• Registration Number: NCT01328236
• Lead Sponsor: Clinical Service, China

Brief 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).

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-21
• Last Update Posted: 2011-09-22
• Primary Completion: 2013-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 > Ⅲ grade and ejection fraction > 45%
• Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care

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Exclusion Criteria

• has taken Bortezomib
• KPS ≤ 60 scores
• mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
V-DD single arm	Liposome doxorubicin	INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
V-DD single arm	Dexamethasone	INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
V-DD single arm	Bortezomib	INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

Primary Outcome Measures

Name	Time	Method
overall response rate	Day 1 of every treatment cycle	The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria

Secondary Outcome Measures

Name	Time	Method
the rate of response	Day 1 of every treatment cycle	The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
partial remission rate	Day 1 of every treatment cycle	The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
duration of response	up to 6 months
overall survival	up to two and a half year
Adverse Events	up to two and a half years	Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
FACT/GOC-Ntx	Day 1 of every treatment cycle

Trial Locations

Locations (1)

Beijing Clinical Service Center; 🇨🇳 Beijing, Beijing, China