Multiple Myeloma, Plasma Cell LeukemiaPhase 1NCT01248923
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing ARRY-520, KSP(Eg5) inhibitor; intravenous, Bortezomib, proteasome inhibitor; intravenous or subcutaneous and Dexamethasone, steroid; oral in people with Multiple Myeloma, Plasma Cell Leukemia, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 13 sites in United States.
Trial summary
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 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, Bortezomib, proteasome inhibitor; intravenous or subcutaneous and Dexamethasone, steroid; oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2010to Mar 2016
- Phase
- Phase 1
- 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 relapsed or refractory MM (measurable disease) or PCL.
- Prior treatment regimens for Part 1: Patients should have received at least 2 prior treatment regimens. Prior treatment must have included at least one full cycle of a proteasome inhibitor (e.g., bortezomib or carfilzomib) and at least one full cycle of an IMiD (e.g., thalidomide, lenalidomide or pomalidomide).
- Prior treatment regimens for Part 2: Patients should have received 1 to 3 prior treatment regimens. Prior treatment could have included bortezomib only if the disease was not refractory to treatment with bortezomib (refractory defined as documented progression on therapy or within 60 days of completing treatment with bortezomib).
- The disease should have progressed per IMWG criteria during or after the last prior treatment regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematology laboratory values without transfusion support and without hematological growth factor support within 2 weeks of screening.
- Adequate liver and renal function.
- Additional criteria exist.
Who cannot join
- Primary amyloidosis.
- Peripheral neuropathy ≥ Grade 2 or neuropathy with pain, regardless of grade.
- 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.
- Treatment with an investigational medicinal product or device within 28 days prior to first dose of study drug.
- Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
Show all 11Show fewer
- 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).
- Major surgery within 14 days and minor surgery within 7 days prior to first dose of study drug.
- Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days 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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414
Baylor Charles A. Sammons Cancer Center at Dallas
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
The Jones Clinic
Germantown, Tennessee, 38138
Clearview Cancer Institute
Huntsville, Alabama, 35805
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
NYU Cancer Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Associates in Oncology/Hematology
Rockville, Maryland, 20850
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
About this study
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).
In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Being tested
- ARRY-520, KSP(Eg5) inhibitor; intravenous, Bortezomib, proteasome inhibitor; intravenous or subcutaneous, Dexamethasone, steroid; oral, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- Keywords
- relapsed multiple myeloma, 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.
Bortezomib, proteasome inhibitor; intravenous or subcutaneousDrug
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Dexamethasone, steroid; oralDrug
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDrug
Part 1: standard of care; Part 2: standard of care.
ARRY-520, KSP(Eg5) inhibitor; intravenousDrug
Part 1: multiple dose, escalating
Bortezomib, proteasome inhibitor; intravenous or subcutaneousDrug
Part 1: standard of care
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDrug
Part 1: standard of care
| Study group | Role | What they receive |
|---|---|---|
| ARRY-520 (Schedule 1) + bortezomib + G-CSF | Experimental | Not described Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
| ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF | Experimental | Not described Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous; Drug: Dexamethasone, steroid; oral; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
| ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF | Experimental | Not described Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous; Drug: Dexamethasone, steroid; oral; 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.
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 1
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
Measured: Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
Measured: Part 2
Secondary outcomes (3)
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.
Measured: Part 1 and Part 2
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 2
Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.
Measured: Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, Plasma Cell LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248923
- Sponsor's protocol ID
- ARRAY-520-111
- Status last verified
- Sep 2020
- First submitted
- 24 Nov 2010
- Last updated
- 30 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01248923
- Acronym / sponsor ID
- ARRAY-520-111
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Keywords
- relapsed multiple myeloma, plasma cell dyscrasia, plasmacytoma, kinesin spindle protein, anti-mitotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2016 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).
In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARRY-520 (Schedule 1) + bortezomib + G-CSF | Experimental | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous, Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous, Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
| ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF | Experimental | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous, Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous, Drug: Dexamethasone, steroid; oral, Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
| ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF | Experimental | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous, Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous, Drug: Dexamethasone, steroid; oral, Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed relapsed or refractory MM (measurable disease) or PCL.
- Prior treatment regimens for Part 1: Patients should have received at least 2 prior treatment regimens. Prior treatment must have included at least one full cycle of a proteasome inhibitor (e.g., bortezomib or carfilzomib) and at least one full cycle of an IMiD (e.g., thalidomide, lenalidomide or pomalidomide).
- Prior treatment regimens for Part 2: Patients should have received 1 to 3 prior treatment regimens. Prior treatment could have included bortezomib only if the disease was not refractory to treatment with bortezomib (refractory defined as documented progression on therapy or within 60 days of completing treatment with bortezomib).
- The disease should have progressed per IMWG criteria during or after the last prior treatment regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Key exclusion criteria (11 listed)
- Primary amyloidosis.
- Peripheral neuropathy ≥ Grade 2 or neuropathy with pain, regardless of grade.
- 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.
- Treatment with an investigational medicinal product or device within 28 days prior to first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARRY-520, KSP(Eg5) inhibitor; intravenousPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule. | Drug | ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF, ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF |
| Bortezomib, proteasome inhibitor; intravenous or subcutaneousPart 1: standard of care; Part 2: standard of care determined in Part 1. | Drug | ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF, ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF |
| Dexamethasone, steroid; oralPart 1: standard of care; Part 2: standard of care determined in Part 1. | Drug | ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF, ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF |
| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousPart 1: standard of care; Part 2: standard of care. | Drug | ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF, ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF |
| ARRY-520, KSP(Eg5) inhibitor; intravenousPart 1: multiple dose, escalating | Drug | ARRY-520 (Schedule 1) + bortezomib + G-CSF |
| Bortezomib, proteasome inhibitor; intravenous or subcutaneousPart 1: standard of care | Drug | ARRY-520 (Schedule 1) + bortezomib + G-CSF |
| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousPart 1: standard of care | Drug | ARRY-520 (Schedule 1) + bortezomib + G-CSF |
Primary outcome
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
Time frame: Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
Time frame: Part 2
3 secondary outcomes
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.
Time frame: Part 1 and Part 2
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 2
Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.
Time frame: Part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
Related trials for Multiple Myeloma, Plasma Cell Leukemia
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Plasma Cell Leukemia
RecruitingPhase 2
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Plasma Cell Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARRY-520, KSP(Eg5) inhibitor; intravenous, Bortezomib, proteasome inhibitor; intravenous or subcutaneous and Dexamethasone, steroid; oral in people with Multiple Myeloma, Plasma Cell Leukemia, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 13 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 8 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 30 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 13 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 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.
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?
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms. (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?
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 30 Sep 2020.