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

This study is currently recruiting participants.
Verified September 2011 by Clinical Service, China
Sponsor:
Collaborators:
Harbin Institute of Hematology and Oncology
Shanghai Changzheng Hospital
Chinese PLA General Hospital
Affiliated Hospital to Academy of Military Medical Sciences
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
wangzhao, Clinical Service, China
ClinicalTrials.gov Identifier:
NCT01328236
First received: March 29, 2011
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Plasma Cell Leukemia
Multiple Myeloma
 Drug: Bortezomib
Drug: Liposome doxorubicin
Drug: Dexamethasone
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinical Service, China:

Primary Outcome Measures:
  • overall response rate [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
    The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria


Secondary Outcome Measures:
  • the rate of response [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.

  • partial remission rate [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.

  • duration of response [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: up to two and a half year ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: up to two and a half years ] [ Designated as safety issue: Yes ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.

  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V-DD single arm

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.

 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.

Other Name: Velcade
Drug: 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.
Other Name: Caelyx
Drug: 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.

Other Name: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • has taken Bortezomib
  • KPS ≤ 60 scores
  • mental illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328236

Locations
China, Beijing
Beijing Clinical Service Center Recruiting
Beijing, Beijing, China
Contact: zhao wang, M.D     861063138303 ext 861063138303     zhaowww263@yahoo.com    
Sponsors and Collaborators
Clinical Service, China
Harbin Institute of Hematology and Oncology
Shanghai Changzheng Hospital
Chinese PLA General Hospital
Affiliated Hospital to Academy of Military Medical Sciences
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Investigators
Principal Investigator: zhao wang, Master Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: wangzhao, Beijing Friendship Hospital, Clinical Service, China
ClinicalTrials.gov Identifier: NCT01328236     History of Changes
Obsolete Identifiers: NCT01327716
Other Study ID Numbers: 26866138CAN2026
Study First Received: March 29, 2011
Last Updated: September 21, 2011
Health Authority: United States: Federal Government

Keywords provided by Clinical Service, China:
Bortezomib
PCL

Additional relevant MeSH terms:
Leukemia
Leukemia, Plasma Cell
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Doxorubicin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013