A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
Status: | Completed |
---|---|
Conditions: | Hematology, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/8/2017 |
Start Date: | May 2014 |
End Date: | September 5, 2017 |
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.
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.
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
We found this trial at
30
sites
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UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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