Daratumumab Open label, dose-escalation safety study in Combination with Lenalidomide and Dexamethasone in Patients with multiple myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

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

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