Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bortezomib Type: Drug
Name: cyclophosphamide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2015.Firstly, All patients included will provide written informed consent.Secondly,they will be randomized equally to receive modified VCD regimen1 arm or modified VCD regimen2 arm.In total, 47 patients per arm (or 94 in total) are required. The Treatment consists of four or six 4-week cycles of induction therapy followed by intensive therapy with auto-transplantation±modified VCD regimens and maintenance treatment with VD or CTD/TD 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Jinling Hospital
Nanjing, Jiangsu, China
Status: Recruiting
Contact: zhai yo ping, doctor - 13951947646 - ypzhai@medmail.com.cn
Start Date
August 2013
Completion Date
August 2017
Sponsors
Yongping Zhai
Source
Jinling Hospital, China
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page