Modified Bortezomib-based Combination Therapy for Multiple Myeloma

NCT ID: NCT02559154

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2018-12-31

Brief Summary

To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

Detailed Description

Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.

The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified BZ group

Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxsnteone

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

conventional BZ group

Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide

Group Type: ACTIVE_COMPARATOR

Bortezomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxsnteone

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

Interventions

Bortezomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxsnteone

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

Other Intervention Names

velcade

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple myeloma based on standard diagnosis criteria:

• plasmacytomas on tissue biopsy
• bone marrow plasmacytosis
• monoclonal immunoglobulin spike on serum electrophoresis
• lytic bone lesions.
• Must have relapsed or relapsed/refractory disease
• 18 years of age or older
• All baseline studies must be performed within 21 days of enrollment.
• ECOG performance status of 0 to 2

Exclusion Criteria

• Renal insufficiency (serum creatinine levels > 2mg/dL)
• Concomitant therapy medications that include corticosteroids
• Peripheral neuropathy of Grade 3 or greater or painful Grade 2
• Evidence of mucosal or internal bleeding and/or platelet refractory
• ANC < 1000 cells/mm3
• Hemoglobin < 8.0 g/dL
• AST (SGOT and ALT) > 2 x ULN
• Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
• Known hypersensitivity to thalidomide or the development of erythema nodosum
• Active infection or serious co-morbid medical condition
• Pregnant or breast-feeding women
• Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Daolin Wei

Principal Investigator,Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guohua Liu, MD

Role: STUDY_CHAIR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, , China

Countries

China

Other Identifiers

2010K059

Identifier Type: -

Identifier Source: org_study_id