A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Hematopoietic stem cell transplant, HSCT, Melphalan, Prednisolone, Bortezomib, JNJ-26866138
Eligibility Criteria
Inclusion Criteria:
- Participants diagnosed with symptomatic or nonsecretory multiple myeloma
- Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
- Participants with a measurable lesion
- Life expectancy greater than or equal to 3 months
Exclusion Criteria:
- Previously received treatment for Multiple Myeloma
- Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
- Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
- Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
- Active prior malignancy diagnosed within the last 5 years
- Female participant who is pregnant or breast-feeding
- Participant is enrolled in another clinical research study and/or is receiving an investigational agent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Phase I: JNJ-26866138 0.7 mg/m2
Phase I: JNJ-26866138 1.0 mg/m2
Phase I: JNJ-26866138 1.3 mg/m2
Phase II: JNJ-26866138 1.3 mg/m2
JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles.
JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles