Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421186
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: MOR03087 phase 1 dose escalation Drug: MOR03087 Drug: Dexamethasone Drug: Pomalidomide Drug: Lenalidomide Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : July 2011
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Phase 1 dose escalation

Part A: MOR03087 dose escalation; biweekly treatment

Part B: MOR03087 dose escalation; weekly treatment

Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone

Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone

Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone

For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment.

 Drug: MOR03087 phase 1 dose escalation

Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.

In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1.


Drug: Dexamethasone
Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.

Drug: Pomalidomide
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Drug: Lenalidomide
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Experimental: Phase 2a confirmatory cohorts

Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone.

Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects.

Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects.

For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.

 Drug: MOR03087
MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.

Drug: Dexamethasone
Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.

Drug: Pomalidomide
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Drug: Lenalidomide
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Determination of maximum tolerated dose and / or recommended dose and dosing regimen of MOR03087 [ Time Frame: First cycle of treatment ]
    1. As monotherapy
    2. In combination with dexamethasone
    3. In combination with pomalidomide + dexamethasone
    4. In combination with lenalidomide + dexamethasone

  2. Safety will be evaluated by assessing adverse events, clinical laboratory data and vital signs [ Time Frame: until PD, maximum 3 years after 1st dose ]
  3. Number of participants who develop anti-MOR03087 antibodies as a measure of immunogenicity [ Time Frame: until PD, maximum 3 years after 1st dose ]

Secondary Outcome Measures :
  1. Pharmacokinetics of MOR03087 +/- lenalidomide or pomalidomide (pharmacokinetic assessment comprises: C max, t max, t 1/2, Total Body Clearance (CL), AUC) [ Time Frame: until PD, maximum 3 years after 1st dose ]
  2. Overall response rate, duration of response, time to progression (TTP) and progression-free survival (PFS) [ Time Frame: maximum 3 years after 1st dose ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 stem cell transplant (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 central nervous system (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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421186


Locations
Layout table for location information
Austria
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I
Vienna, Austria, 1090
Germany
Charité - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie
Berlin, Germany, 12200
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Medizinische Universitätsklinik, Abt. Innere Medizin I
Freiburg, Germany, 79106
Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum
Heidelberg, Germany, 69120
Sektion für Stammzell- und Immuntherapie, II. Medizinischen Klinik,
Kiel, Germany, 24105
Klinikum rechts der Isar/ Studien / III. Med. Klinik
Munich, Germany, 81675
Medizinische Klinik II, Abt. Hämatologie, Onkologie,
Tübingen, Germany, 7206
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie
Würzburg, Germany, 97080
Sponsors and Collaborators
MorphoSys AG
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01421186    
Other Study ID Numbers: MOR202C101
DRKS00003145 ( Registry Identifier: German Clinical Trail Register )
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Keywords provided by MorphoSys AG:
Multiple Myeloma
MOR03087 (MOR202)
Lenalidomide
Pomalidomide
CD38
Additional relevant MeSH terms:
Layout table for 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
 Lenalidomide
Pomalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors