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

NCT ID: NCT01868828

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-05-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PAD

Intervention Type: DRUG

Induction Therapy of PAD for 4 cycles.

ASCT

Intervention Type: OTHER

Not suitable for transplant patients will continue accept treatment for 8 cycles.

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.

Group Type: EXPERIMENTAL

VCD

Intervention Type: DRUG

Induction Therapy of VCD for 4 cycles.

ASCT

Intervention Type: OTHER

Not suitable for transplant patients will continue accept treatment for 8 cycles.

Interventions

PAD

Induction Therapy of PAD for 4 cycles.

Intervention Type: DRUG

VCD

Induction Therapy of VCD for 4 cycles.

Intervention Type: DRUG

ASCT

Not suitable for transplant patients will continue accept treatment for 8 cycles.

Intervention Type: OTHER

Other Intervention Names

Induction Therapy; Induction Therapy

Eligibility Criteria

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.

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin Lu, PhD

Role: CONTACT

onco_velcade123@163.com

Facility Contacts

Jin Lu, PhD

Role: primary

onco_velcade123@163.com

Other Identifiers

PAD VS VCD Clinical Protocol

Identifier Type: -

Identifier Source: org_study_id