NCT00985959 - A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) | Biotech Hunter

Enrollment

101

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions

Multiple Myeloma

Interventions

DRUG

JNJ-26866138 0.7 mg/m2

JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles.

DRUG

JNJ-26866138 1.0 mg/m2

JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles

DRUG

JNJ-26866138 1.3 mg/m2

Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.

DRUG

Melphalan

Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

DRUG

Prednisolone

Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Trial Locations (28)

Unknown

Fukuoka

Hiroshima

Hitachi

Isehara

Kamogawa

Kanazawa

Kawagoe

Kobe

Kōtoku

Kumamoto

Kurashiki

Kurume

Kyoto

Nagasaki

Nagoya

Narita

Niigata

Okayama

Ōsaka-sayama

Sapporo

Shibukawa

Suita

Tokushima

Tokyo

Toyama

Toyohashi

Utsunomiya

Yokohama