Status:
COMPLETED
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
MorphoSys AG
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refract...
Detailed Description
The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment reg...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years and older
- Relapsed or refractory multiple myeloma defined as:
- Parts A, B and C:
- (i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
- Part D:
- (i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma
- Part E:
- (i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
- Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period
- Absolute neutrophil count (ANC) ≥ 1,000 / mm3
- Haemoglobin ≥ 8 g/dL
- Ability to comply with all study related procedures, medication use and evaluations
Exclusion
- Primary refractory multiple myeloma
- History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
- Treatment with systemic investigational agent within 28 days prior to first study treatment
- Solitary plasmacytoma or plasma cell leukaemia
- Previous allogenic stem cell transplant (SCT)
- Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment
- Active systemic infection
- Systemic disease preventing study treatment
- Multiple myeloma with central nervous system (CNS) involvement
- Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed)
- Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association \[NYHA\] classes III, IV)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01421186
Start Date
July 1 2011
End Date
August 1 2020
Last Update
November 16 2021
Active Locations (10)
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1
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I
Vienna, Austria, 1090
2
Charité - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie
Berlin, Germany, 12200
3
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
4
Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen
Erlangen, Germany, 91054