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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

Tracking Information
First Submitted Date  ICMJE April 18, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE May 23, 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03136653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • 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
  • Determine the immunogenicity of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    assess anti-drug antibodies
  • Determine PFS of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    Time (months) to date of tumor progression or death
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • Estimate efficacy in terms of overall survival (OS) of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    OS
  • Characterize the PK of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    plasma concentrations over time
  • Characterize potential biomarkers of MP0250 plus BOR + DEX [ Time Frame: 24 months ]
    biomarkers
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma
Official Title  ICMJE A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma in Relapse
Intervention  ICMJE 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.

Study Arms Experimental: single arm study MP0250 plus BOR + DEX
single arm study of MP0250 plus bortezomib + dexamethasone
Intervention: Biological: MP0250 plus BOR+DEX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Medical Director, MPAG +41 44 755 7700 info@molecularpartners.com
Listed Location Countries  ICMJE Germany,   Italy,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136653
Other Study ID Numbers  ICMJE MP0250-CP201
2016-002771-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Molecular Partners AG
Study Sponsor  ICMJE Molecular Partners AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Molecular Partners AG
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP