A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)

NCT02092922

Last updated date
Study Location
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35249, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Multiple MyelomaA Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
NCT02092922
  1. Birmingham, Alabama
  2. Duarte, California
  3. San Francisco, California
  4. Aurora, Colorado
  5. Denver, Colorado
  6. New Haven, Connecticut
  7. Atlanta, Georgia
  8. Chicago, Illinois
  9. Chicago, Illinois
  10. Decatur, Illinois
  11. Westwood, Kansas
  12. Lexington, Kentucky
  13. Louisville, Kentucky
  14. Bethesda, Maryland
  15. Boston, Massachusetts
  16. Detroit, Michigan
  17. Saint Louis, Missouri
  18. Lincoln, Nebraska
  19. Las Vegas, Nevada
  20. New York, New York
  21. New York, New York
  22. Charlotte, North Carolina
  23. Durham, North Carolina
  24. Cleveland, Ohio
  25. Charleston, South Carolina
  26. Dallas, Texas
  27. Houston, Texas
  28. Salt Lake City, Utah
  29. Spokane Valley, Washington
  30. Bruxelles,
  31. Leuven,
  32. Calgary, Alberta
  33. Halifax, Nova Scotia
  34. Montreal, Quebec
  35. Bierre-Benite Cedex,
  36. Lille Cedex,
  37. Marseille Cedex 9,
  38. Nantes Cedex,
  39. Nimes Cedex 9,
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  41. Tours Cedex,
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  45. Heidelberg,
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  47. Tubingen,
  48. Wurzburg,
  49. Athens,
  50. Athens,
  51. Badalona,
  52. Barcelona,
  53. Valencia,
  54. Valencia,
  55. Zaragoza,
  56. London,
  57. London,
  58. Southhampton,
  59. Surrey,
  60. Wolverhampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Multiple MyelomaA Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT01989325
  1. Hot Springs, Arkansas
  2. Los Angeles, California
  3. Santa Rosa, California
  4. Fort Myers, Florida
  5. Chicago, Illinois
  6. Marrero, Louisiana
  7. Boston, Massachusetts
  8. Detroit, Michigan
  9. Hattiesburg, Mississippi
  10. Omaha, Nebraska
  11. New York, New York
  12. Charlotte, North Carolina
  13. Cincinnati, Ohio
  14. Cleveland, Ohio
  15. Columbus, Ohio
  16. Portland, Oregon
  17. Watertown, South Dakota
  18. Nashville, Tennessee
  19. Dallas, Texas
  20. Fairfax, Virginia
  21. Morgantown, West Virginia
  22. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Filanesib, KSP (Eg5) inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    standard of care
Study Arms  ICMJE Experimental: Filanesib
Interventions:
  • Drug: Filanesib, KSP (Eg5) inhibitor; intravenous
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
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
 (submitted: July 27, 2016)
154
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2014)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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