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

August 27, 2017 updated by: Yongping Zhai

Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: modified VCD regimen1

Induction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen1 for 5 cycles.

Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month.

Interventions:

Drug: Bortezomib 1.6mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data.
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.
Other Names:
  • Velcade
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.
Other Names:
  • Endoxan, Cytoxan, Neosar, Procytox, Revimmune
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.
Other Names:
  • Acidocont,Deronil,Dexacortal,dexametona,Flumeprednisolon
Experimental: modified VCD regimen2

Induction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen 2 for 5 cycles.

Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month.

Interventions:

Drug: Bortezomib 1.3mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data.
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.
Other Names:
  • Velcade
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.
Other Names:
  • Endoxan, Cytoxan, Neosar, Procytox, Revimmune
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.
Other Names:
  • Acidocont,Deronil,Dexacortal,dexametona,Flumeprednisolon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of complete remission
Time Frame: 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.
Day 1 of every treatment cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: up to two year
PFS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
up to two year
Adverse Events
Time Frame: up to two years
Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0
up to two years
overall response rates (ORR)
Time Frame: 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.
Day 1 of every treatment cycle
duration of response
Time Frame: up to 6 months
Duration of response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
up to 6 months
overall survival (OS)
Time Frame: up to two year
The rate of OS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
up to two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongping Zhai

Investigators

  • Principal Investigator: zhai yo ping, doctor, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 27, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAB20130806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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