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

NCT01328236 | Unknown Phase 2 DMC

• 1 other identifier: 26866138CAN2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Plasma Cell Leukemia; Multiple Myeloma

Keywords

Bortezomib; PCL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• the rate of response

  Day 1 of every treatment cycle

• partial remission rate

  Day 1 of every treatment cycle

• 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

Study Arms (1)

V-DD single arm

EXPERIMENTAL

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; Drug: Liposome doxorubicin; Drug: Dexamethasone

Interventions

Bortezomib DRUG

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.

Also known as: Velcade

V-DD single arm

Liposome doxorubicin DRUG

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.

Also known as: Caelyx

V-DD single arm

Dexamethasone DRUG

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.

Also known as: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon

V-DD single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Service, China: lead
• Harbin Hematology and Oncology Institute: collaborator
• Shanghai Changzheng Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• 307 Hospital of PLA: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Beijing Chao Yang Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Peking University Third Hospital: collaborator

Study Sites (1)

Beijing Clinical Service Center

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Plasma Cell; Multiple Myeloma

Interventions

Bortezomib; liposomal doxorubicin; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• zhao wang, Master

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Friendship Hospital

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 4, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2015
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

CN (1)