A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 in Relapsed/Refractory Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by MorphoSys AG
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01421186
First received: July 29, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti CD38 antibody MOR03087 in adult subjects with relapsed/refractory multiple myeloma as monotherapy and in adult subjects with relapsed/refractory multiple myeloma as combination with standard therapy.


Condition Intervention Phase
Multiple Myeloma
Drug: MOR03087
Drug: MOR03087, Bortezomib, Dexamethasone
Drug: MOR03087, Lenalidomide, Dexamethasone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MorphoSys AG:

Primary Outcome Measures:
  • 1. Determination of maximum tolerated dose and / or recommended dose [ Time Frame: after all patients have completed the first 2 cycles of treatment (up to 20 weeks) ] [ Designated as safety issue: Yes ]
  • 2. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs [ Time Frame: every 2 to 4 weeks ] [ Designated as safety issue: Yes ]
  • 3. Number of participants who develop anti-MOR03087 antibodies as a measure of immunogenicity [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Pharmacokinetics of MOR03087 (Pharmacokinetic assessment comprises: C max, t max, t 1/2, CL, AVC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • 2. Overall response rate based on standard response criteria, change from baseline in serum M protein levels [ Time Frame: monthly (approximately 1 year) ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I Dose escalation Drug: MOR03087
Intravenous infusion of MOR03087 for up to 2 cycles
Experimental: Phase IIa Monotherapy extension Drug: MOR03087
Intravenous infusion of MOR03087 for up to 4 cycles
Experimental: Phase Ib MOR03087 combined with bortezomib Drug: MOR03087, Bortezomib, Dexamethasone
Intravenous infusion of MOR03087 in combination with intravenous injection of bortezomib (and if applicable, addition of dexamethasone)
Experimental: Phase Ib MOR03087 combined with lenalidomide Drug: MOR03087, Lenalidomide, Dexamethasone
Intravenous infusion of MOR03087 in combination with oral lenalidomide and dexamethasone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  3. Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg/24-h period and / or serum FLCs ≥ 10 mg/100 mL (≥ 100 mg/L) combined with an abnormal ratio of lambda and kappa chains
  4. ANC ≥ 1.0 (1,000 / mm3) and platelets ≥ 80x10E9/L
  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 screening visit
  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 screening visit
  7. Active systemic infection
  8. Systemic disease preventing study treatment
  9. Multiple myeloma with CNS involvement
  10. Active treatment / chemotherapy for other primary malignancy within past 3 years
  11. Significant uncontrolled cardiovascular disease or cardiac insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421186

Contacts
Contact: Samson Fung +49898999270 info@morphosys.com

Locations
Austria
Universitätsklinikum Graz, Auenbruggerplatz 38 Recruiting
Graz, Austria, 8036
Allgemeines Krankenhaus Wien, Währinger Gürtel 18-20 Recruiting
Wien, Austria, 1090
Germany
Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum, Im Neuenheimer Feld 410 Recruiting
Heidelberg, Germany, 69120
Klinikum rechts der Isar/ Studien / III. Med. Klinik/ Ismaninger Str. 22 Recruiting
Munich, Germany, 81675
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie, Oberdürrbacher Straße 6 Recruiting
Würzburg, Germany, 97080
Sponsors and Collaborators
MorphoSys AG
  More Information

No publications provided

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01421186     History of Changes
Other Study ID Numbers: MOR202C101, DRKS00003145
Study First Received: July 29, 2011
Last Updated: June 27, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Bundesamt für Sicherheit im Gesundheitswesen

Keywords provided by MorphoSys AG:
Multiple Myeloma
MOR03087
Lenalidomide
Bortezomib
CD38

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 18, 2014