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Advanced Multiple MyelomaPhase 2NCT02092922

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

A Phase 2 study testing Filanesib, KSP (Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous in people with Advanced Multiple Myeloma, run by Pfizer at 60 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Multiple Myeloma
What is being tested?
Filanesib, KSP (Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
60 sitesin 8 countries
Study dates
May 2014to 5 Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed multiple myeloma whose treatment history must include all of the following:
  • Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
  • 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).
  • 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:
  • A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
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  • Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

60 sites in 8 countries.

60 sites in 8 countries

United States29 sites

  • Emory University, Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35249

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Nebraska Hematology Oncology, P.C.

    Lincoln, Nebraska, 68506

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06510

  • Mount Sinai Medical Center

    New York, New York, 10029

  • NY Presbyterian - Weill Cornell Medical Center

    New York, New York, 10065

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Washington University in St. Louis

    St Louis, Missouri, 63130

  • University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

Other trials in United States

France8 sites

  • Centre Hospitalier Lyon-Sud

    Bierre-Benite Cedex

  • Hopital Claude Huriez

    Lille

  • Institut Paoli Calmettes

    Marseille

  • CHU Hotel Dieu

    Nantes

  • G.H.U Caremeau

    Nîmes

  • Institut Universitaire de Cancer

    Toulouse

  • CHU tours-Hopital Bretonneau

    Tours

  • CHU de Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Germany6 sites

  • TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I

    Dresden

  • Asklepios Kliniken Hamburg GmbH

    Hamburg

  • University Hospital Heidelberg

    Heidelberg

  • University Hospital Leipzig

    Leipzig

  • University of Tubingen

    Tübingen

  • Julius Maximilians Universitat Wurzburg

    Würzburg

Other trials in Germany

Spain5 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Universitario La Fe

    Valencia

  • Hospital Quiron de Zaragoza

    Zaragoza

Other trials in Spain

United Kingdom5 sites

  • Barts Health NHS Trust

    London

  • Kings College Hospital NHS Foundation Trust

    London

  • Southhampton General Hospital

    Southhampton

  • The Royal Marsden NHS Foundation Trust

    Surrey

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

Canada3 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • QEII Health Sciences Center

    Halifax, Nova Scotia

  • Jewish General Hospital

    Montreal, Quebec

Other trials in Canada

Belgium2 sites

  • Institut Jules Bordet

    Brussels

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

Greece2 sites

  • General Hospital of Athens "Evangelismos"

    Athens

  • University of Athens School of Medicine

    Athens

Other trials in Greece

About this study

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.

Being tested
Filanesib, KSP (Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filanesib, KSP (Eg5) inhibitor; intravenousDrug

    multiple dose, single schedule

  • Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDrug

    standard of care

Study groups in NCT02092922
Study groupRoleWhat they receive
FilanesibExperimentalNot described
Receives: Drug: Filanesib, KSP (Eg5) inhibitor; intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.

    Measured: up to 2 years

Secondary outcomes (7)

  1. In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.

    Measured: up to 2 years

  2. In all patients, assess the efficacy of the study drug in terms of duration of response.

    Measured: up to 2 years

  3. In all patients, assess the efficacy of the study drug in terms of progression-free survival.

    Measured: up to 2 years

  4. In all patients, assess the efficacy of study drug in terms of overall survival.

    Measured: up to 2 years

  5. In all patients, assess the safety of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Measured: up to 2 years

  6. In a subset of all patients, characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentration-time profiles.

    Measured: 6 months

  7. In a subset of all patients, assess the correlation between study drug exposure and changes in corrected QT interval (QTc) in terms of changes in QTc versus time-matched study drug plasma concentrations.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2016
  4. Study completion5 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02092922
Sponsor's protocol ID
ARRAY-520-215
Other IDs
2014-001051-23, C4371002, 2014
Status last verified
Oct 2020
First submitted
19 Mar 2014
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filanesib, KSP (Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous in people with Advanced Multiple Myeloma, run by Pfizer at 60 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, France, Germany, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate. (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02092922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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