A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma

Molecular Partners AG24 sites in 6 countries33 target enrollmentMay 23, 2017

ConditionsMultiple Myeloma in Relapse

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma in Relapse
Sponsor: Molecular Partners AG
Enrollment: 33
Locations: 24
Primary Endpoint: Part 2: ORR
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

MP0250 is a multi-DARPin® drug candidate 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.

Registry

clinicaltrials.gov

Start Date

May 23, 2017

End Date

January 13, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Molecular Partners AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with MM who have received:
•Part 1 ≥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
•Part 2 ≥2 lines of prior therapy that included a proteasome inhibitor (bortezomib, carfilzomib or both) and an IMiD (thalidomide, lenalidomide and/or pomalidomide) either alone or in combination and a response no better than SD lasting at least 4 months on a bortezomib- or carfilzomib-based regimen as last line of therapy or progression on treatment or within 60 days of stopping a bortezomib- or carfilzomib-based regimen as last line of therapy. Note: For transplant-eligible patients enrolled to Part 1 or Part 2, induction plus conditioning chemotherapy/ASCT +/- maintenance therapy constitute one regimen.
•Presence of a measurable disease with at least one of the following criteria:
•Serum M protein ≥0.5 g/dL, or
•Urine M protein ≥200 mg/24 h, or
•Involved serum free light chain (FLC) levels \>100 mg/L and abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M protein, or
•For patients with immunoglobulin A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥0.5g/dL.
•Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
•Life expectancy \>3 months

Exclusion Criteria

•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,
•Myelodysplastic syndrome,
•Plasma cell leukemia defined as a plasma cell count \>2000/mm3
•Polyneuropathy, organomegaly endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
•Peripheral neuropathy Grade 2 or higher at Screening or patients with a history of Grade 3/4 neuropathy or Grade 2 with pain

Outcomes

Primary Outcomes

Part 2: ORR

Time Frame: 24 months

Defined as the number of participants achieving a confirmed, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 2.

Part 1: Overall Response Rate (ORR)

Time Frame: 24 months

Defined as the number of participants achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 1.

Secondary Outcomes

Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Results(24 months)
Progression Free Survival (PFS)(24 months)
Number of Participants who Experienced One or More Treatment-Emergent SAEs(24 months)
Number of Participants with a Clinical Significant Change from Baseline in Laboratory Results(24 months)
Number of Participants Who Experienced One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 Adverse Events(24 months)
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events(24 months)
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs(24 months)
Titer of Anti-drug Antibodies (ADA)(24 months)
Number of Participants with a Positive Anti-drug Antibody (ADA) Result(24 months)
Time Course of Anti-drug Antibodies(24 months)
Duration of Response (DOR)(24 months)