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

• Sponsor: Clinical Service, China (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01328236
• Collaborator: Harbin Hematology and Oncology Institute (Other), Shanghai Changzheng Hospital (Other), Chinese PLA General Hospital (Other), 307 Hospital of PLA (Other), Wuhan Union Hospital, China (Other), Beijing Chao Yang Hospital (Other), Henan Provincial People's Hospital (Other), Peking University Third Hospital (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• 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: Sep 1, 2010
• Anticipated Primary Completion Date: Sep 1, 2013
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

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 Names: 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 Names: 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 Names: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. duration of response [up to 6 months]

4. overall survival [up to two and a half year]

5. Adverse Events [up to two and a half years]

   Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Beijing Clinical Service Center	Beijing	Beijing	China

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 People's Hospital
• Peking University Third Hospital

Investigators

• Principal Investigator: zhao wang, Master, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: wangzhao, Beijing Friendship Hospital, Clinical Service, China
• ClinicalTrials.gov Identifier: NCT01328236
• Other Study ID Numbers: 26866138CAN2026; NCT01327716
• First Posted: Apr 4, 2011
• Last Update Posted: Sep 22, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by wangzhao, Beijing Friendship Hospital, Clinical Service, China: Bortezomib; PCL
• Additional relevant MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Plasma Cell; Dexamethasone; Doxorubicin; Bortezomib

Study Results

No Results Posted as of Sep 22, 2011