Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yongping Zhai
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Teniposide

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