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

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

Bortezomib

Dexamethasone

Doxorubicin

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, cyclophosphamide, bortezomib, doxorubicin, peripheral neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sun Yat-sen university cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CyBorD regimen

PAD regimen

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02362165

First Posted

February 8, 2015

Last Updated

April 18, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02362165

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

multiple myeloma, cyclophosphamide, bortezomib, doxorubicin, peripheral neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CyBorD regimen

Arm Type

Experimental

Arm 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.

Arm Title

PAD regimen

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

endoxan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

velcade

Intervention Description

1.3mg/㎡,once-weekly,subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

40mg/d,once-weekly,per oral

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

adriamycin

Intervention Description

9mg/㎡,d1-4

Primary Outcome Measure Information:

Title

At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy

Description

Time Frame

date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

Secondary Outcome Measure Information:

Title

complete response rate(according to the criteria IMWG) after four cycles of induction therapy

Description

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

Time Frame

date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

Title

At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy

Description

Time Frame

date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang Wang, Doctor

Phone

+862087342439

wangliang@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhongjun Xia, Doctor

Phone

+862087342438

xiazhj@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongjun Xia, Doctor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen university cancer center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhongjun Xia, MD

Phone

020-87342439

xiazhj@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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