Multiple Myeloma
Conditions
Brief summary
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2017.Firstly, All patients included will provide written informed consent. Secondly, they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of four 4-week cycles of induction therapy followed by intensive therapy with another five modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version 3.0.Response categories were based on the International Myeloma Working Group uniform response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.
Interventions
DRUGBortezomib
Induction therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,4 cycle Intensive therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,5 cycles.
DRUGcyclophosphamide
Induction therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,4 cycles. Intensive therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,5 cycles. Maintenance treatment with CP: 200mg PO Days 1-14 of each 28 day cycles,12 cycles.
DRUGDexamethasone
Induction therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,4 cycles Intensive therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,5 cycles.
Sponsors
Yongping Zhai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with previously untreated symptomatic MM * 18 years of age or older, regardless of gender * secretory MM with measurable diseases * Karnofsky Performance Status≥50%（pathological fractures excluded） * Patients without heart and pulmonary dysfunction ≤class I
Exclusion criteria
* peripheral neuropathy of grade 2 or higher according to NCI-CTCAE Version 3.0 * Relapse and refractory MM * MM without symptom * Non-secretory MM without measurable diseases * Karnofsky Performance Status\<50%（pathological fractures excluded） * Patients with heart and pulmonary dysfunction\> class I
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of complete remission | Day 1 of every treatment cycle | The rate of complete remission of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | up to two year | PFS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria. |
| Adverse Events | up to two years | Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0 |
| overall response rates (ORR) | Day 1 of every treatment cycle | The rate of overall response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria. |
| duration of response | up to 6 months | Duration of response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria. |
| overall survival (OS) | up to two year | The rate of OS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria. |
Countries
China
Contacts
Primary Contactzhai yo ping, doctor
Backup Contactli feng, master
Outcome results
None listed