A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as Monotherapy and in Combination with Standard Therapy in Subjects with Relapsed/Refractory Multiple Myeloma
- Conditions
- C90.0Multiple myeloma
- Registration Number
- DRKS00003145
- Lead Sponsor
- MorphoSys AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 91
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:
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Determination of maximum tolerated dose and / or recommended dose<br>2. Incidence and severity of adverse events<br>3. Immunogenicity (evaluated at end of study, Anti-MOR03087-Antibodies)<br>
- Secondary Outcome Measures
Name Time Method 1. Pharmacokinetics<br>2. Preliminary efficacy (at end of study, myeloma response based on IMWG Uniform Response Criteria (2006))<br>