An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

NCT01675245 | Completed

• 3 other identifiers: CR00637326866138MMY4031VEL-CHN-MA-01
• Study Type: observational
• Target: 532
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Cancer; Velcade; Bortezomib; Chinese patients

Outcome Measures

Primary Outcomes (29)

• Information on treatment sequence for Velcade therapy

  Treatment sequence or the line of therapy will be considered on Velcade utilization.

  Baseline (Day -1) to Day 21

• Information on dosage of Velcade

  Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.

  Baseline to Day 21

• Information on duration of Velcade therapy

  Duration of Velcade therapy will be measured on Velcade utilization. The unit of duration will be number of days or the length of the course of therapy.

  Baseline to Day 21

• Information on patient diagnosis for Velcade therapy

  Diagnosis of patients will be considered on Velcade utilization.

  Baseline to Day 21

• Number of patients with disease response or progression

  Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.

  Up to 3 years

• Time to response

  Time to response is calculated from the start date of the cycle of Velcade therapy.

  Up to 3 years

• Duration of response

  Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.

  Up to 3 years

• Time to progression

  Time to progression is calculated from the date on which response is documented until PD or RCR occurs.

  Up to 3 years

• Survival status

  Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.

  Up to 3 years

• Number of patients with adverse events

  Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria \[WHO CTC\]), and any neurotoxic events by WHO CTC.

  Up to 3 years

• Number of emergency room visits while using Velcade therapy

  Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.

  Up to 3 years

• Number of inpatient hospital stays while using Velcade therapy

  Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.

  Up to 3 years

• Number of days for each hospital stay

  Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.

  Up to 3 years

• Number of patients on whom therapeutic therapies will be conducted

  Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.

  Up to 3 years

• Number of patients on whom chest radiograph will be conducted

  Up to 3 years

• Number of patients on whom whole-body bone scan will be conducted

  Up to 3 years

• Number of patients on whom radiograph for designated area will be conducted

  Up to 3 years

• Serum immunoglobin and M-protein

  Up to 3 years

• M-protein detected by immunofixation electrophoresis

  Up to 3 years

• Urine light chain M-protein

  Up to 3 years

• Bone marrow puncture and biopsy

  Up to 3 years

• β2-microglobulin

  Up to 3 years

• C-reactive protein

  Up to 3 years

• Lactate dehydrogenase

  Up to 3 years

• Routine blood examination

  Up to 3 years

• Liver function test

  Up to 3 years

• Renal function test

  Up to 3 years

• Serum electrolytes

  Up to 3 years

• Number of patients on concomitant medications

  Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy. Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication. The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.

  Up to 3 years

Secondary Outcomes (4)

• Indications for Velcade therapy

  Baseline (Day -1)

• Sociodemographics for Velcade therapy

  Baseline

• Number of chronic concomitant disease

  Baseline

• Treatment history

  Baseline

Study Arms (1)

Velcade

Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.

Drug: No intervention

Interventions

No intervention DRUG

This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)

Velcade

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.

You may qualify if:

• Must give informed consent in agreement with local legislation
• Must not have any contraindication listed in package insert

You may not qualify if:

• Patients currently participating in another investigational study of Velcade or any other medication
• Patients with severe hepatic or renal impairment
• Patients with platelet count below 25000/μl
• Patients who are considered disqualified for the study by the investigators

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Related Publications (1)

• Lin M, Hou J, Chen W, Huang X, Liu Z, Zhou Y, Li Y, Zhao T, Wang L, Wu KW, Shen Z. Improved response rates with bortezomib in relapsed or refractory multiple myeloma: an observational study in Chinese patients. Adv Ther. 2014 Oct;31(10):1082-94. doi: 10.1007/s12325-014-0159-z. Epub 2014 Oct 21.

  PMID: 25331616 DERIVED

Related Links

• VELCADE (Bortezomib for Injection) Observational Study

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; 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

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: March 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 11, 2014

Record last verified: 2014-06