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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Doxorubicin; Drug: Bortezomib; Drug: Dexamethasone; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02362165

SYSUCC-MM-308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

CyBorD regimen

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Dexamethasone

Drug: Bortezomib

PAD regimen

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Bortezomib

Drug: Doxorubicin