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

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ClinicalTrials.gov Identifier: NCT02362165
Recruitment Status : Unknown
Verified April 2016 by Xia Zhongjun, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Xia Zhongjun, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cyclophosphamide Drug: Bortezomib Drug: Dexamethasone Drug: Doxorubicin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: 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.
Drug: Cyclophosphamide
500mg/d,once-weekly,per oral.
Other Name: endoxan

Drug: Bortezomib
1.3mg/㎡,once-weekly,subcutaneous injection
Other Name: velcade

Drug: Dexamethasone
40mg/d,once-weekly,per oral

Active Comparator: 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.
Drug: Bortezomib
1.3mg/㎡,once-weekly,subcutaneous injection
Other Name: velcade

Drug: Dexamethasone
40mg/d,once-weekly,per oral

Drug: Doxorubicin
9mg/㎡,d1-4
Other Name: adriamycin




Primary Outcome Measures :
  1. At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy [ Time Frame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months) ]
    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 :
  1. complete response rate(according to the criteria IMWG) after four cycles of induction therapy [ Time Frame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months) ]
    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

  2. At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy [ Time Frame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months) ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362165


Contacts
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Contact: Liang Wang, Doctor +862087342439 wangliang@sysucc.org.cn
Contact: Zhongjun Xia, Doctor +862087342438 xiazhj@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen university cancer center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhongjun Xia, MD    020-87342439    xiazhj@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhongjun Xia, Doctor Sun Yat-sen University

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Responsible Party: Xia Zhongjun, Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02362165     History of Changes
Other Study ID Numbers: SYSUCC-MM-308
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Xia Zhongjun, Sun Yat-sen University:
multiple myeloma
cyclophosphamide
bortezomib
doxorubicin
peripheral neuropathy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists