A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
NCT02092922
ABOUT THIS STUDY
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- Patients with confirmed multiple myeloma whose treatment history must include all of the following:
1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
2. Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
3. Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.
- Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:
1. A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
2. Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
3. Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug.
- Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
- Additional criteria exist.
Key
- Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and
skin changes).
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to
first dose of study drug.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with
less than a 2-year disease-free interval at the time of first dose of study drug.
Patients with adequately resected basal or squamous cell carcinoma of the skin,
carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible
irrespective of the time of diagnosis.
- Use of an investigational agent that is not expected to be cleared by the time of
first dose of study drug or that has been demonstrated to have prolonged side effects.
Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia
and neuropathy).
- Any severe concurrent disease or condition (including severe graft-versus-host
disease, requirement for dialysis, symptomatic congestive heart failure [New York
Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia)
which, in the judgment of the Investigator, would make the patient inappropriate for
study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B
and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM) | ||||||
Official Title ICMJE | Not Provided | ||||||
Brief Summary | The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study. Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Advanced Multiple Myeloma | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Filanesib
Interventions:
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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 | Completed | ||||||
Actual Enrollment ICMJE | 154 | ||||||
Original Estimated Enrollment ICMJE | 160 | ||||||
Actual Study Completion Date ICMJE | September 5, 2017 | ||||||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Canada, France, Germany, Greece, Spain, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02092922 | ||||||
Other Study ID Numbers ICMJE | ARRAY-520-215 2014-001051-23 ( EudraCT Number ) C4371002 ( Other Identifier: Pfizer ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |