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

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ClinicalTrials.gov Identifier: NCT01328236
Recruitment Status : Unknown
Verified September 2011 by wangzhao, Clinical Service, China.
Recruitment status was:  Recruiting
First Posted : April 4, 2011
Last Update Posted : September 22, 2011
Sponsor:
Collaborators:
Harbin Hematology and Oncology Institute
Shanghai Changzheng Hospital
Chinese PLA General Hospital
307 Hospital of PLA
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
wangzhao, 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).


Condition or disease Intervention/treatment Phase
Plasma Cell Leukemia Multiple Myeloma Drug: Bortezomib Drug: Liposome doxorubicin Drug: Dexamethasone Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Study Start Date : September 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2015


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. overall response rate [ Time Frame: 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 :
  1. the rate of response [ Time Frame: 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.

  2. partial remission rate [ Time Frame: 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.

  3. duration of response [ Time Frame: up to 6 months ]
  4. overall survival [ Time Frame: up to two and a half year ]
  5. Adverse Events [ Time Frame: up to two and a half years ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.

  6. FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hematology and Oncology Institute
Shanghai Changzheng Hospital
Chinese PLA General Hospital
307 Hospital of PLA
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Investigators
Principal Investigator: zhao wang, Master Beijing Friendship Hospital

Responsible Party: wangzhao, Beijing Friendship Hospital, Clinical Service, China
ClinicalTrials.gov Identifier: NCT01328236     History of Changes
Obsolete Identifiers: NCT01327716
Other Study ID Numbers: 26866138CAN2026
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by wangzhao, Clinical Service, China:
Bortezomib
PCL

Additional relevant MeSH terms:
Leukemia
Multiple Myeloma
Leukemia, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Liposomal doxorubicin
Doxorubicin
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones