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

Clinical Service, China

Status and phase: Unknown; Phase 2

Conditions: Plasma Cell Leukemia; Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Bortezomib; Drug: Liposome doxorubicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01328236

26866138CAN2026

Details and patient eligibility

About

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).

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

V-DD single arm

Experimental group

Description:

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.

Treatment:

Drug: Liposome doxorubicin

Drug: Bortezomib

Drug: Dexamethasone