C90.0
Conditions
Interventions
Group 1: Drug: MOR03087, biweekly intravenous infusion, up to 16 mg/kg
Group 2: Drug: MOR03087, weekly intravenous infusion, up to 16 mg/kg
Group 3: Drug: MOR03087, weekly intravenous infusion, up to
Sponsors
MorphoSys AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Male or female subjects 18 years and older 2. Relapsed or refractory multiple myeloma defined as failure of at least 2 previous therapies, at least 1 previosus failed therpapy for the LEN arm 3. Presence of serum M-protein = 0.5 g per 100 mL (= 5 g/L) and / or urine M-protein = 200 mg/24-h 4. ANC = 1.0 (1,000 / mm3) 5. Haemoglobin = 8 g/dL 6. Ability to comply with all study related procedures, medication use and evaluations
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Primary refractory multiple myeloma 2. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher 3. Treatment with systemic investigational agent within 28 days prior to treatment start 4. Solitary plasmocytoma or plasma cell leukaemia 5. Previous allogenic SCT 6. Prior therapy with other monoclonal antibodies targeting the CD38 antigen and prior therapy with other IgG monoclonal antibodies within 3 months prior to screening and IgM monoclonal antibodies within 1 month prior to treatment start 7. Active systemic infection 8. Systemic disease preventing study treatment 9. Multiple myeloma with CNS involment 10. Active treatment / chemotherapy for other primary malignancy within past 3 years, 5 years for the POM or LEN arm 11. Significant uncontrolled cardiovascular disease or cardiac insufficiency
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics 2. Preliminary efficacy (at end of study, myeloma response based on IMWG Uniform Response Criteria (2006)) | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of maximum tolerated dose and / or recommended dose 2. Incidence and severity of adverse events 3. Immunogenicity (evaluated at end of study, Anti-MOR03087-Antibodies) | — |
Countries
Austria, Germany
Contacts
Public ContactWinrich Rauschning
MorphoSys AG
Outcome results
None listed