Clinical trial NCT02362165: CyBorD vs. PAD in the Treatment of Newly Diagnosed Multiple Myeloma
Official title: A Phase 3 Trial Comparing Cyclophosphamide,Bortezomib,and Dexamethasone (CyBorD) and Bortezomib,Doxorubicin,and Dexamethasone (PAD) in the Treatment of Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: multiple myeloma
cyclophosphamide
bortezomib
doxorubicin
peripheral neuropathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy
timeFrame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)
Secondary outcomes:
measure: complete response rate(according to the criteria IMWG) after four cycles of induction therapy
timeFrame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)
measure: At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy
timeFrame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen university cancer center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhongjun Xia, Doctor
role: PRINCIPAL_INVESTIGATOR
References: