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

NCT02086942 | Unknown Phase 2 DMC

• 1 other identifier: NAB20130806
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• the rate of complete remission

  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 Outcomes (5)

• progression free survival

  up to two year

• Adverse Events

  up to two years

• overall response rates (ORR)

  Day 1 of every treatment cycle

• duration of response

  up to 6 months

• overall survival (OS)

  up to two year

Study Arms (2)

modified VCD regimen1

EXPERIMENTAL

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; Drug: cyclophosphamide; Drug: Dexamethasone

modified VCD regimen2

EXPERIMENTAL

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; Drug: cyclophosphamide; Drug: Dexamethasone

Interventions

Bortezomib DRUG

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.

Also known as: Velcade

modified VCD regimen1; modified VCD regimen2

cyclophosphamide DRUG

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.

Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune

modified VCD regimen1; modified VCD regimen2

Dexamethasone DRUG

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.

Also known as: Acidocont,Deronil,Dexacortal,dexametona,Flumeprednisolon

modified VCD regimen1; modified VCD regimen2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previously untreated symptomatic MM
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yongping Zhai: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (1)

• Li F, Yao FS, Zhu XJ, Gu WY, Wang XH, Chen B, Huang DP, Ding JH, Wu TQ, Zhu Y, Zhao Q, Tang YM, Song P, Zhou XG, An ZM, Guo X, Wang XL, Zhong L, Xie XB, Zhai YP. A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients. J Cancer Res Clin Oncol. 2019 Sep;145(9):2343-2355. doi: 10.1007/s00432-019-02967-3. Epub 2019 Jul 6.

  PMID: 31280348 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Cyclophosphamide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• zhai yo ping, doctor

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhai yo ping, doctor

CONTACT

13951947646; zhaiyongping66@163.com

li feng, master

CONTACT

13851815062; kerry8848@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of hemotology

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 13, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

CN (1)