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Advanced Multiple MyelomaPhase 2NCT01989325

A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma

A Phase 2 study testing Carfilzomib, proteasome inhibitor; intravenous, Filanesib, KSP(Eg5) inhibitor; intravenous and Dexamethasone, steroid; oral or intravenous in people with Advanced Multiple Myeloma, run by Pfizer at 22 sites in United States.

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

This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). 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?
Carfilzomib, proteasome inhibitor; intravenous, Filanesib, KSP(Eg5) inhibitor; intravenous and Dexamethasone, steroid; oral or intravenous
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
22 sitesUnited States
Study dates
Nov 2013to May 2016
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

  • Confirmed multiple myeloma with measurable disease.
  • Disease refractory to last myeloma regimen.
  • Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
  • Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
  • Additional criteria exist.

Who cannot join

  • Prior treatment with carfilzomib, filanesib, 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).
  • Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
  • Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
Show all 12Show fewer
  • 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 treatment. 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.
  • Known pulmonary hypertension of any severity.
  • Concurrent cardiac disease that, 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

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Oncology Hematology Care - Blue Ash

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Simmons Cancer Center - UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Forrest General Cancer Center

    Hattiesburg, Mississippi, 39401

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • UCLA

    Los Angeles, California, 90095

  • Crescent City Research Consortium

    Marrero, Louisiana, 70072

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • WVU - Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Knight Cancer Institute at Oregon Health & Science University

    Portland, Oregon, 97239

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Prairie Lakes Health Care System

    Watertown, South Dakota, 57201

Other trials in United States

About this study

This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.

Being tested
Carfilzomib, proteasome inhibitor; intravenous, Filanesib, KSP(Eg5) inhibitor; intravenous, Dexamethasone, steroid; oral or 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.

  • Carfilzomib, proteasome inhibitor; intravenousDrug

    multiple dose, single schedule

  • Filanesib, KSP(Eg5) inhibitor; intravenousDrug

    multiple dose, single schedule

  • Dexamethasone, steroid; oral or intravenousDrug

    as indicated, per the carfilzomib prescribing information

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

    standard of care

Study groups in NCT01989325
Study groupRoleWhat they receive
Carfilzomib + FilanesibExperimentalSingle agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
Receives: Drug: Carfilzomib, proteasome inhibitor; intravenous; Drug: Filanesib, KSP(Eg5) inhibitor; intravenous; Drug: Dexamethasone, steroid; oral or intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
CarfilzomibExperimentalSingle agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Receives: Drug: Carfilzomib, proteasome inhibitor; intravenous; Drug: Dexamethasone, steroid; oral or intravenous

What is being measured

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

  1. Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.

    Measured: 18 months

Secondary outcomes (5)

  1. Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.

    Measured: 18 months

  2. Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Measured: 18 months

  3. Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.

    Measured: 6 months

  4. Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.

    Measured: 18 months

  5. Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Measured: 18 months

Timeline

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

  1. First posted21 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionFeb 2016
  4. Study completionMay 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989325
Sponsor's protocol ID
ARRAY-520-216
Status last verified
Sep 2020
First submitted
5 Nov 2013
Last updated
16 Sep 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 Carfilzomib, proteasome inhibitor; intravenous, Filanesib, KSP(Eg5) inhibitor; intravenous and Dexamethasone, steroid; oral or intravenous in people with Advanced Multiple Myeloma, run by Pfizer at 22 sites in United States.

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 6 inclusion and 12 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. 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?

Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival. (time frame: 18 months). 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 NCT01989325.

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 16 Sep 2020.

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