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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02362165
• Other study ID #: SYSUCC-MM-308
• Status: Recruiting
• Phase: Phase 3
• First received: February 8, 2015
• Last updated: April 18, 2016
• Start date: April 2015
• Est. completion date: May 2018

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: Liang Wang, Doctor
• Phone: +862087342439
• Email: wangliang[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Cyclophosphamide
500mg/d,once-weekly,per oral.
• Bortezomib
1.3mg/?,once-weekly,subcutaneous injection
• Dexamethasone
40mg/d,once-weekly,per oral
• Doxorubicin
9mg/?,d1-4

Locations

Country	Name	City	State
China	Sun Yat-sen university cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy	compare the Response assessment in both arms: the Very good partial response rate (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD	date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)	No
Secondary	complete response rate(according to the criteria IMWG) after four cycles of induction therapy	compare the Response assessment in both arms: the complete response rate (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD	date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)	No
Secondary	At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy	compare the Response assessment in both arms: the at least partial response rate (CR+VGPR+PR) (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD	date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)	No