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

NCT02086942 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-08-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bortezomib

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.

DRUG

cyclophosphamide

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.

DRUG

Dexamethasone

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 & Collaborators

  • Yongping Zhai

    lead OTHER

Principal Investigators

  • zhai yo ping, doctor · Jinling Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02086942 on ClinicalTrials.gov