Trial | NCT01328236  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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).
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
Study Started
Sep 30
2010
Primary Completion
Sep 30
2013
Anticipated
Study Completion
Sep 30
2015
Anticipated
Last Update
Sep 22
2011
Estimate

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

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.

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
No Results Posted