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

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ClinicalTrials.gov Identifier: NCT02086942
Recruitment Status : Unknown
Verified August 2017 by Yongping Zhai, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Yongping Zhai, Jinling Hospital, China

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Drug: cyclophosphamide Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.
Study Start Date : August 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Acidocont,Deronil,Dexacortal,dexametona,Flumeprednisolon




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Adverse Events [ Time Frame: up to two years ]
    Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086942


Contacts
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Contact: zhai yo ping, doctor 13951947646 zhaiyongping66@163.com
Contact: li feng, master 13851815062 kerry8848@sina.com

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: zhai yo ping, doctor    13951947646    ypzhai@medmail.com.cn   
Sponsors and Collaborators
Yongping Zhai
Investigators
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Principal Investigator: zhai yo ping, doctor Jinling Hospital, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yongping Zhai, Department of hemotology, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02086942     History of Changes
Other Study ID Numbers: NAB20130806
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Bortezomib
Teniposide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal