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Multiple MyelomaPhase 1/2NCT00821249

A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing ARRY-520, KSP(Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous and Dexamethasone, steroid; oral in people with Multiple Myeloma and Plasma Cell Leukemia, run by Pfizer at 5 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 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520. The study has 3 parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Plasma Cell Leukemia
What is being tested?
ARRY-520, KSP(Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous and Dexamethasone, steroid; oral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
5 sitesUnited States
Study dates
Jan 2009to 16 Mar 2016
Phase
Phase 1/2
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 should have received at least two prior treatment regimens.
  • Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens.
  • Previously received adequate alkylator therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate hematology laboratory values without transfusion support within 2 weeks of screening.
  • Adequate liver and renal function.
  • Additional criteria exist.

Who cannot join

  • Primary amyloidosis.
  • Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis).
  • Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
  • Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
  • Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
  • Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
  • Additional criteria exist.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University, Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520.

The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting).

Read more

In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).

In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).

Being tested
ARRY-520, KSP(Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous, Dexamethasone, steroid; oral
Keywords
plasma cell dyscrasia, plasmacytoma, kinesin spindle protein, anti-mitotic
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Paraproteinemias, Plasmacytoma

What participants receive

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

  • ARRY-520, KSP(Eg5) inhibitor; intravenousDrug

    Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

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

    Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.

  • Dexamethasone, steroid; oralDrug

    Part 3: standard of care.

Study groups in NCT00821249
Study groupRoleWhat they receive
ARRY-520ExperimentalNot described
Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
ARRY-520 + G-CSF supportExperimentalNot described
Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
ARRY-520 + dexamethasone + G-CSF supportExperimentalNot described
Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous; Drug: Dexamethasone, steroid; oral

What is being measured

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

  1. Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

    Measured: Part 1

  2. Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.

    Measured: Part 2 and Part 3

  3. Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Measured: Part 3

Secondary outcomes (5)

  1. Characterize the pharmacokinetics of the study drug.

    Measured: Part 1

  2. Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment.

    Measured: Part 1

  3. Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Measured: Part 2

  4. Assess the efficacy of the study drug, with and without dexamethasone, in terms of duration of response, progression-free survival, treatment-free survival, time to next treatment and overall survival.

    Measured: Part 2 and Part 3

  5. Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.

    Measured: Part 1, Part 2 and Part 3

Timeline

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

  1. First posted13 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completion16 Mar 2016
  4. Study completion16 Mar 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821249
Sponsor's protocol ID
ARRAY-520-212
Status last verified
Oct 2020
First submitted
9 Jan 2009
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.

Publications

  • Shah JJ, Kaufman JL, Zonder JA, Cohen AD, Bensinger WI, Hilder BW, Rush SA, Walker DH, Tunquist BJ, Litwiler KS, Ptaszynski M, Orlowski RZ, Lonial S. A Phase 1 and 2 study of Filanesib alone and in combination with low-dose dexamethasone in relapsed/refractory multiple myeloma. Cancer. 2017 Dec 1;123(23):4617-4630. doi: 10.1002/cncr.30892. Epub 2017 Aug 17.

    PubMed 28817190

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARRY-520, KSP(Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous and Dexamethasone, steroid; oral in people with Multiple Myeloma and Plasma Cell Leukemia, run by Pfizer at 5 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 7 inclusion and 8 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 5 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF. (time frame: Part 1). The study lists 3 primary outcomes in all. 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 NCT00821249, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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