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

NCT01868828 | Unknown Phase 4

• 1 other identifier: PAD VS VCD Clinical Protocol
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Combination Therapy

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Up to cycle 4 (with 28 days per cycle).

Secondary Outcomes (5)

• Safety

  At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.

• Overall Response Rate

  At baseline, on day 28 of each cycle for 4 cycles.

• Time To Response

  At baseline, on day 28 of each cycle for 4 cycles.

• 1-year Survival Rate

  At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.

• Overall Survival

  At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.

Study Arms (2)

PAD Followed by ASCT

EXPERIMENTAL

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; Other: ASCT

VCD Followed by ASCT

EXPERIMENTAL

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.

Drug: VCD; Other: ASCT

Interventions

PAD DRUG

Induction Therapy of PAD for 4 cycles.

Also known as: Induction Therapy

PAD Followed by ASCT

VCD DRUG

Induction Therapy of VCD for 4 cycles.

Also known as: Induction Therapy

VCD Followed by ASCT

ASCT OTHER

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

PAD Followed by ASCT; VCD Followed by ASCT

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Neoadjuvant Therapy

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)

Combined Modality Therapy; Therapeutics

Study Officials

• Jin Lu, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Lu, PhD

CONTACT

onco_velcade123@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2017
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

CN (1)