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

June 4, 2013 updated by: Jin Lu, Peking University People's Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

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
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital, Institute of Hematology, Peking University
        • 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

No older than 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PAD Followed by ASCT

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: PAD
Induction Therapy of PAD for 4 cycles.
Other Names:
  • Induction Therapy
Other: ASCT
Not suitable for transplant patients will continue accept treatment for 8 cycles.
EXPERIMENTAL: VCD Followed by ASCT

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.
Other: ASCT
Not suitable for transplant patients will continue accept treatment for 8 cycles.
Drug: VCD
Induction Therapy of VCD for 4 cycles.
Other Names:
  • Induction Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Response Rate
Time Frame: Up to cycle 4 (with 28 days per cycle).
Up to cycle 4 (with 28 days per cycle).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
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.
At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Response Rate
Time Frame: At baseline, on day 28 of each cycle for 4 cycles.
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.
At baseline, on day 28 of each cycle for 4 cycles.
Time To Response
Time Frame: At baseline, on day 28 of each cycle for 4 cycles.
At baseline, on day 28 of each cycle for 4 cycles.
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.
At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Survival
Time Frame: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

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

May 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAD VS VCD Clinical Protocol

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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