A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, MOR03087 (MOR202), Lenalidomide, Pomalidomide, CD38
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MOR03087 phase 1 dose escalation Type: Drug
Name: MOR03087 Type: Drug
Name: Dexamethasone Type: Drug
Name: Pomalidomide Type: Drug
Name: Lenalidomide Type: Drug
Overall Status
Recruiting
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/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Male or female subjects 18 years and older

2. 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

3. 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

4. Absolute neutrophil count (ANC) ≥ 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 first study treatment

4. Solitary plasmacytoma or plasma cell leukaemia

5. Previous allogenic SCT

6. 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

7. Active systemic infection

8. Systemic disease preventing study treatment

9. Multiple myeloma with CNS involvement

10. 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)

11. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Locations
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I
Vienna, Austria
Status: Recruiting
Charité - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie
Berlin, Germany
Status: Recruiting
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Status: Recruiting
Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen
Erlangen, Germany
Status: Recruiting
Medizinische Universitätsklinik, Abt. Innere Medizin I
Freiburg, Germany
Status: Recruiting
Asklepios Klinik Altona, II. Medizinische Abteilung für Hämatologie/Onkologie
Hamburg, Germany
Status: Recruiting
Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum
Heidelberg, Germany
Status: Recruiting
Sektion für Stammzell- und Immuntherapie, II. Medizinischen Klinik,
Kiel, Germany
Status: Recruiting
Klinikum rechts der Isar/ Studien / III. Med. Klinik
Munich, Germany
Status: Recruiting
Medizinische Klinik II, Abt. Hämatologie, Onkologie,
Tübingen, Germany
Status: Recruiting
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie
Würzburg, Germany
Status: Recruiting
Start Date
July 2011
Completion Date
May 2018
Sponsors
MorphoSys AG
Source
MorphoSys AG
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page