Status:
COMPLETED
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness an...
Detailed Description
This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00985959
Start Date
July 1 2008
End Date
June 1 2010
Last Update
December 2 2013
Active Locations (28)
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1
Fukuoka, Japan
2
Hiroshima, Japan
3
Hitachi, Japan
4
Isehara, Japan