"Kahler's disease" "Malignant growth of plasma cells"
Conditions
Interventions
Skeletal survey:
X-rays or CT scan of the entire body, including the skull, is required.
Additional studies (X-ray, CT scan or
MRI) can be performed, this is at the discretion of the investigator (
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Before entering Phase 1 of the study, subjects must: 1. Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with Len/Dex. 2. Have measurable levels of M component, defined as serum M component* 1.0 g/dL and/or urine M component * 200 mg/24 hour sample. 3. Be * 18 years of age. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Attachment 1). 5. Have a life expectancy of * 3 months. 6. Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed.;Before entering Phase 2 of the study, subjects must: 1. - Have received at least 1 prior line of therapy for multiple myeloma (refer to Attachment 2). - Have achieved a response (PR or better) to at least one prior regimen. - Have documented evidence of progressive disease (PD) as defined by the IMWG criteria on or after their last regimen. 2. Have measurable levels of M component, defined as serum M component * 1.0 g/dL and/or urine M component * 200 mg/24 hour sample. 3. Be * 18 years of age. 4. Have an ECOG performance status score of 0, 1, or 2 (Attachment 1). 5. Have a life expectancy of * 3 months. 6. Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed.
Exclusion criteria
Exclusion criteria: 1. Have previously received an allogenic stem cell transplant. 2. Have received auto SCT within 12 weeks before the first infusion. 3. Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion. 4.Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either: - Subjects whose disease progresses within 60 days of lenalidomide, or - Subjects whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an MR or development of PD while on lenalidomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main variable for this study, the incidence of side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points are: - The rate of response - Pharmacokinetic parameters - The time to progression - Duration of response - Survival | — |
Countries
Netherlands
Outcome results
None listed