Multiple Myeloma
Conditions
Keywords
multiple myeloma, cyclophosphamide, bortezomib, doxorubicin, peripheral neuropathy
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.
Interventions
DRUGCyclophosphamide
500mg/d,once-weekly,per oral.
DRUGBortezomib
1.3mg/㎡,once-weekly,subcutaneous injection
DRUGDexamethasone
40mg/d,once-weekly,per oral
DRUGDoxorubicin
9mg/㎡,d1-4
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| complete response rate(according to the criteria IMWG) after four cycles of induction therapy | 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 |
| At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy | 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 |
Countries
China
Contacts
Primary ContactLiang Wang, Doctor
Backup ContactZhongjun Xia, Doctor
Outcome results
None listed