An Open label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma
- Conditions
- Kahler's diseaseMalignant growth of plasma cells10035227
- Registration Number
- NL-OMON47233
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main variable for this study, the incidence of side effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary end points are:<br /><br>- The rate of response<br /><br>- Pharmacokinetic parameters<br /><br>- The time to progression<br /><br>- Duration of response<br /><br>- Survival</p><br>