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A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PAD
VCD
ASCT
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Combination Therapy

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women aged <65 years.
  2. Previously untreated subjects with multiple myeloma.
  3. No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) < 500).
  4. Pulmonary infection (if any) must be controlled effectively.
  5. Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）；
  6. Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN).
  7. Expected lifetime More than 3 months.
  8. Be able to read and sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

  1. Patients with relapsed multiple myeloma.
  2. Need to change the program according to the researchers' evaluated patients with disease progression during treatment.
  3. Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
  4. Has a history of allergic reaction to compounds containing boron or mannitol.
  5. Severe neuropathy may affect the treatment, according to the researchers to determine.
  6. According to the program or the investigator's judgment, the patient is suffering from a serious physical illness or mental illness may interfere with participation in this clinical study.
  7. Concurrent treatment with another investigational agent.
  8. Pregnant or breast-feeding women.

Sites / Locations

  • Peking University People's Hospital, Institute of Hematology, Peking UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PAD Followed by ASCT

VCD Followed by ASCT

Arm Description

Drug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles.

Drug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles.

Outcomes

Primary Outcome Measures

Complete Response Rate

Secondary Outcome Measures

Safety
Safety evaluations will be based on scheduled clinical laboratory tests, electrocardiogram or cardiac ultrasonography (when appropriate), vital signs, physical examination and number of adverse events.
Overall Response Rate
Overall response rate included Complete Response (CR), Very good partial response (VGPR) and PR, before the new treatment, two consecutive evaluations are in line with defined criteria in order to confirm the efficacy evaluation.
Time To Response
1-year Survival Rate
Overall Survival

Full Information

First Posted
May 22, 2013
Last Updated
June 4, 2013
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01868828
Brief Title
A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma
Official Title
A Multicenter, Double Arms, Prospective Phase 4 Study to Evaluating the Efficacy and Safety of Combination Therapy of PAD Versus VCD Treatment in Previously Untreated Subjects With Multiple Myeloma.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up.
Detailed Description
Screening At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria. Treatment Eligible patients are randomly assigned to receive either treatment PAD or VCD. All eligible subjects will be evaluated after 4 cycles treatment. According to the assessment of researchers and the willingness of patients to decide whether to autologous stem-cell transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem cell transplantation. Not suitable for transplant patients will continue accept treatment for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy evaluation. Follow-up All patients will receive 12 months of follow-up after the treatment period. Follow-up at 4, 6, 8 and 12 month after the treatment period respectively. Subjects who have disease progression or accept other resistance myeloma therapy during the 12 months of follow-up phase will stop assessed about the study and start followed up only for survival status every 6 months through telephone interviews or to research center follow-up. All patients will accept the follow-up for survival until last case patient who complete follow-up. Safety will be evaluated throughout the study by assessment of adverse events (AEs), physical examination, vital signs and clinical laboratory findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Combination Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAD Followed by ASCT
Arm Type
Experimental
Arm Description
Drug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles.
Arm Title
VCD Followed by ASCT
Arm Type
Experimental
Arm Description
Drug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles.
Intervention Type
Drug
Intervention Name(s)
PAD
Other Intervention Name(s)
Induction Therapy
Intervention Description
Induction Therapy of PAD for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
VCD
Other Intervention Name(s)
Induction Therapy
Intervention Description
Induction Therapy of VCD for 4 cycles.
Intervention Type
Other
Intervention Name(s)
ASCT
Intervention Description
Not suitable for transplant patients will continue accept treatment for 8 cycles.
Primary Outcome Measure Information:
Title
Complete Response Rate
Time Frame
Up to cycle 4 (with 28 days per cycle).
Secondary Outcome Measure Information:
Title
Safety
Description
Safety evaluations will be based on scheduled clinical laboratory tests, electrocardiogram or cardiac ultrasonography (when appropriate), vital signs, physical examination and number of adverse events.
Time Frame
At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Title
Overall Response Rate
Description
Overall response rate included Complete Response (CR), Very good partial response (VGPR) and PR, before the new treatment, two consecutive evaluations are in line with defined criteria in order to confirm the efficacy evaluation.
Time Frame
At baseline, on day 28 of each cycle for 4 cycles.
Title
Time To Response
Time Frame
At baseline, on day 28 of each cycle for 4 cycles.
Title
1-year Survival Rate
Time Frame
At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Title
Overall Survival
Time Frame
At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged <65 years. Previously untreated subjects with multiple myeloma. No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) < 500). Pulmonary infection (if any) must be controlled effectively. Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）； Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN). Expected lifetime More than 3 months. Be able to read and sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: Patients with relapsed multiple myeloma. Need to change the program according to the researchers' evaluated patients with disease progression during treatment. Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis. Has a history of allergic reaction to compounds containing boron or mannitol. Severe neuropathy may affect the treatment, according to the researchers to determine. According to the program or the investigator's judgment, the patient is suffering from a serious physical illness or mental illness may interfere with participation in this clinical study. Concurrent treatment with another investigational agent. Pregnant or breast-feeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Lu, PhD
Email
onco_velcade123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Lu, PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital, Institute of Hematology, Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Lu, PhD
Email
onco_velcade123@163.com

12. IPD Sharing Statement

Learn more about this trial

A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma

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