Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00752518
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2008-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients
Sponsor:
Janssen Pharmaceutical K.K.
Organization:
Study Overview
Official Title:
A Phase I/II Study of JNJ-26866138 (Bortezomib) in Japanese Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.
Detailed Description:
In Japan, there is no clear treatment guidance for patients with multiple myeloma that repeatedly relapsed and became refractory. At present, various therapies including other multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other experimental therapies are conducted exploratory as salvage therapies to find the one to which the patient shows response. Considering that the antitumor activity of JNJ-26866138 against relapsed or refractory MM is clear and and the tolerability is acceptable based on results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which consisting of the two parts: the Phase I part is intended to intravenously administer JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated at the Japanese RD.
Based on the body surface area calculated before treatment in each cycle, the dose is calculated for each patient according to the dose level specified by the Patient Enrollment Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period (Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6 cycles in patients expected to show a response.
Based on the body surface area calculated before treatment in each cycle, the dose is calculated for each patient according to the dose level specified by the Patient Enrollment Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period (Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6 cycles in patients expected to show a response.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: