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A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03136653
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Brief Summary:

The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).

MP0250 is a multi-DARPin with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.


Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Biological: MP0250 plus BOR+DEX Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: single arm study MP0250 plus BOR + DEX
single arm study of MP0250 plus bortezomib + dexamethasone
Biological: MP0250 plus BOR+DEX

6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label.

Number of Cycles: until progression or unacceptable toxicity develops.





Primary Outcome Measures :
  1. Estimate the efficacy of MP0250 plus BOR + DEX based on overall response rate (ORR) [ Time Frame: 24 months ]
    proportion of patients achieving CR, VGPR or PR according to the IMWG criteria


Secondary Outcome Measures :
  1. Determine the safety profile of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    type, frequency and severity of adverse events based on CTCAE 4.03

  2. Determine the immunogenicity of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    assess anti-drug antibodies

  3. Determine PFS of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    Time (months) to date of tumor progression or death

  4. Determine DOR of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    duration from first observation of PR to the time of disease progression or death


Other Outcome Measures:
  1. Estimate efficacy in terms of overall survival (OS) of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    OS

  2. Characterize the PK of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    plasma concentrations over time

  3. Characterize potential biomarkers of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with MM who have received ≥2 lines of therapy (including bortezomib and an IMiD) and have shown no response (i.e. stable disease) to, have progressed on the most recent treatment or have progressed within 60 days of the most recent therapy
  2. Presence of a measurable disease
  3. Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
  4. Adequate hepatic function
  5. Absolute neutrophil count (ANC) ≥1000/mm3 at Screening
  6. Hemoglobin ≥8.0 g/dL at Screening.
  7. Platelet count ≥50 000/mm3 at Screening.
  8. Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/min at Screening based on the Cockcroft and Gault formula
  9. Serum albumin concentration ≥ 30 g/L
  10. Males and females ≥18 years of age
  11. Capable of giving signed informed consent

Exclusion Criteria:

  1. Patients with the following diseases:

    Monoclonal gammopathy of undetermined significance (MGUS) of non- immunoglobulin (Ig)M and IgM subtypes, Light chain MGUS, Solitary plasmacytoma (alone or with minimal marrow involvement), Systemic Ig light chain amyloidosis, Waldenstrom's Macroglobulinemia

  2. Peripheral neuropathy Grade 2 or higher at Screening
  3. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention.
  4. Uncontrolled hypertension
  5. Stroke, or transient ischemic attack within 6 months of Screening

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): NCT03136653


Contacts
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Contact: Medical Director, MPAG +41 44 755 7700 info@molecularpartners.com

Locations
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Germany
University of Essen, Haematology Recruiting
Essen, Germany
University of Heidelberg, Haematology, Oncology Recruiting
Heidelberg, Germany
University of Würzburg, Haematology, Oncology Recruiting
Würzburg, Germany
Italy
University of Bari Medical School, Oncology Recruiting
Bari, Italy
Healthcare Institution Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, Italy
University of Turin, Oncology Recruiting
Turin, Italy
Poland
Medical University of Gdańsk, Haematology Recruiting
Gdańsk, Poland
University of Krakow, Haematology Recruiting
Kraków, Poland
Medical University of Lublin, Haematology Recruiting
Lublin, Poland
Sponsors and Collaborators
Molecular Partners AG

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Responsible Party: Molecular Partners AG
ClinicalTrials.gov Identifier: NCT03136653     History of Changes
Other Study ID Numbers: MP0250-CP201
2016-002771-10 ( EudraCT Number )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molecular Partners AG:
DARPin
MP0250
VEGF
HGF
RRMM
Additional relevant MeSH terms:
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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
Dexamethasone acetate
Bortezomib
BB 1101
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
Protease Inhibitors