CyBorD vs. PAD in the Treatment of Newly Diagnosed Multiple Myeloma

NCT ID: NCT02362165

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-05-31

Brief Summary

Bortezomib-based triple-drug combination has greatly improved the response rate of multiple myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical practice.Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients.In this study, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.

Detailed Description

Bortezomib-based triple-drug combination has greatly improved the response rate of multiple myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical practice. Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients. Moreover, studies have found that subcutaneous injection of bortezomib can decrease the incidence rate of peripheral neuropathy induced by bortezomib, however, most center use twice-weekly administration of bortezomib. According to our experience, once-weekly subcutaneous injection of bortezomib can further decrease the incidence rate of peripheral neuropathy without compromising the efficacy. Thus, in this phase 3 trial, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

CyBorD regimen

this arm will receive cyclophosphamide (500mg/d,once-weekly),bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), and dexamethasone (40mg/d,once-weekly)(CyBorD) as induction therapy.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

500mg/d,once-weekly,per oral.

Bortezomib

Intervention Type: DRUG

1.3mg/㎡,once-weekly,subcutaneous injection

Dexamethasone

Intervention Type: DRUG

40mg/d,once-weekly,per oral

PAD regimen

this arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.

Group Type: ACTIVE_COMPARATOR

Bortezomib

Intervention Type: DRUG

1.3mg/㎡,once-weekly,subcutaneous injection

Dexamethasone

Intervention Type: DRUG

40mg/d,once-weekly,per oral

Doxorubicin

Intervention Type: DRUG

9mg/㎡,d1-4

Interventions

Cyclophosphamide

500mg/d,once-weekly,per oral.

Intervention Type: DRUG

Bortezomib

1.3mg/㎡,once-weekly,subcutaneous injection

Intervention Type: DRUG

Dexamethasone

40mg/d,once-weekly,per oral

Intervention Type: DRUG

Doxorubicin

9mg/㎡,d1-4

Intervention Type: DRUG

Other Intervention Names

endoxan; velcade; adriamycin

Eligibility Criteria

Inclusion Criteria

• Newly diagnosis of multiple myeloma
• Eastern Cooperative Oncology Group (ECOG) status 0-3,
• Estimated survival time > 3 months
• Acceptable liver function (bilirubin<2.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)<2.5×ULN)
• No history of other malignancies
• No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
• No other serious diseases which conflict with the treatment in the present trial
• No concurrent treatments that conflict with the treatments in the present trial
• Voluntary participation and signed the informed consent.

Exclusion Criteria

• The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
• The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
• The patients with neuropathy
• The patients with mentally ill / unable to obtain informed consent
• The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
• The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
• The patients with a history of allergy to test drug
• The patients not suitable to participate in the investigator judged by researchers.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xia Zhongjun

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongjun Xia, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Wang, Doctor

Role: CONTACT

wangliang@sysucc.org.cn

+862087342439

Zhongjun Xia, Doctor

Role: CONTACT

xiazhj@sysucc.org.cn

+862087342438

Facility Contacts

Zhongjun Xia, MD

Role: primary

xiazhj@sysucc.org.cn

020-87342439

Other Identifiers

SYSUCC-MM-308

Identifier Type: -

Identifier Source: org_study_id