A study of the experimental drug KW-2478 in combination with Bortezomib in patients with multiple myeloma.
- Conditions
- Multiple MyelomaMedDRA version: 13.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016223-56-GB
- Lead Sponsor
- Kyowa Hakko Kirin Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 95
1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed.
2. Signed either an IRB or IEC approved informed consent
3. ECOG performance status of = 2
4. Life expectancy of at least 3 months
5. M protein in either serum or urine, clonal bone marrow plasma cells >10%, and evidence of end organ damage
6. Adequate hematologic status, liver and renal function
7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
1. No anti-cancer treatment for = 4 weeks and no bortezomib treatment = 60 days prior to receiving study drug
2. Any other severe, acute or chronic illness
3. No other prior or concurrent malignancy
4. No immunosuppressant therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method