A Phase II, Open-Label Trial Using VELCADE for Re-Treatment of Multiple Myeloma Subjects Following an Initial Response to VELCADE - ND

• Conditions: Multiple myeloma; MedDRA version: 6.1Level: PTClassification code 10028228

• Registration Number: EUCTR2005-005819-26-IT
• Lead Sponsor: Janssen-Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1.Male or female subject, aged major or equal 18 years. 2.Subject previously tolerated 1.0 or 1.3 mg/m2/dose of VELCADE alone or in combination with other agents and had CR or PR upon completion of VELCADE therapy. 3.It has been major or equal 6 months since the subject s last VELCADE dose and the subject has Progressive Disease PD if prior response to VELCADE was PR or subject has relapsed from CR. 4.Subject has a Karnofsky performance status major or equal 60 5.Subject has a life-expectancy 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with a history of PD, minimal response, or stable disease SD on last exposure to VELCADE. 2.Subject has received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of VELCADE. Note Subjects can have received localized palliative radiotherapy for complications due to osteolytic bone lesions. Subjects can have received steroids cumulative exposure of up to 160 mg of Dexamethasone or equivalent or thalidomide or Interferon as maintenance therapy since their last dose of VELCADE. Subjects can have received high dose therapy/stem cell transplantation after VELCADE containing induction regimen, only if PR or CR was observed during VELCADE containing induction therapy. 3.Subjects who achieved a CR or PR but relapsed while on therapy. 4.Subject has oligosecretory or non-secretory multiple myeloma. 5.Subject has an uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had New York Heart Association NYHA Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 6.Subject has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy.;Secondary Objective: The secondary objectives of this study are to assess the safety profile, the best confirmed M-protein response, the duration of response DOR , and time to progression TTP to VELCADE re-treatment in multiple myeloma subjects who have previously responded to VELCADE based therapy. In addition, the exploratory objective of the study is to evaluate the investigator s best response relative to the best reported response to the previous VELCADE course of treatment.;Primary end point(s): To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy.