Multiple MyelomaPhase 2NCT02221479
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
A Phase 2 study testing plerixafor GZ316455 and Filgrastim in people with Multiple Myeloma, run by Genzyme, a Sanofi Company at 5 sites in Japan.
Trial summary
Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- plerixafor GZ316455 and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesJapan
- Study dates
- Oct 2014to Jul 2015
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 75.
- Japanese participants with histological or pathological diagnosis of MM.
- First or second complete response (CR) or partial response (PR).
Who cannot join
- Leukemia participants.
- Myelodysplastic syndrome (MDS) participants.
- Less than 2 weeks since completion of last cycle of chemotherapy.
- Failed previous hematopoietic stem cell (HSC) collections or collection attempts.
- Prior autologous or allogeneic transplant.
- Diagnosis of another malignancy.
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- Known hypersensitivity to plerixafor, G-CSF or their components.
- Bone marrow involvement greater than 10%.
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 1.
- Not yet recovered from all acute toxic effects of prior Chemotherapy.
- White blood cell (WBC) count less than or equal to 2.5 × 10^9 cells/L.
- Absolute neutrophil count (ANC) less than or equal to 1.5 × 10^9 cells /L.
- Platelet count less than or equal to 100 × 10^9 cells /L.
- Creatinine clearance less than 50 mL/min.
- Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than or equal to 2.5 x upper limit of normal,Total Bilirubin greater than or equal to 2.5 x upper limit of normal.
- Cardiac and pulmonary status insufficient to undergo apheresis or transplantation.
- Active central nervous system (CNS) involvement, active brain metastases, or any history of carcinomatous meningitis.
- Active infection, including unexplained fever (greater than 38 degrees C), or antibiotic therapy within 7 days prior to the first dose of GCSF.
- Less than 6 weeks off nitrosoureas prior to first dose of G-CSF.
- Conditions/situations such as: received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine, and received radiation therapy to the pelvis.
- Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the participant's participation in the study.
- Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias) or other conduction abnormality in the last year that, in the opinion of the Investigator(s), warrants exclusion of the participants from the trial.
- Previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the G-CSF and plerixafor treatment period.
- Any malignancy related to immunodeficiency virus (HIV) or solid organ transplant; history of known HIV, unresolved viral hepatitis as documented at the detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb)[exclude patients who clearly received vaccination], hepatitis B core antibody (HBcAb), and/or hepatitis C virus (HCV) antibody at the time of the screening visit.
- Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Related to the active comparator and/or mandatory background therapies.
- Received G-CSF within 7 days prior to the first dose of G-CSF for mobilization.
- Related to the current knowledge of Sanofi compound.
- Pregnant or breast-feeding women.
- All participants, who are sexually active (males and females), must agree to an effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female participants of child-bearing potential and male participants with partners of childbearing potential).
- Patient who has withdrawn consent before enrollment/randomization.
- Despite screening of the patient, enrollment/randomization is stopped at the study level.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Investigational Site Number 392105
Kamogawa-Shi
Investigational Site Number 392103
Kyoto
Investigational Site Number 392102
Nagoya
Investigational Site Number 392104
Okayama
Investigational Site Number 392101
Shibuya-Ku
About this study
Official title: A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Multiple Myeloma
Primary Objective:
To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone.
Read more
Secondary Objectives:
- To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients.
- To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
- To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.
Read the detailed description
Total study duration for a participant can be approximately up to 68 days.
- Conditions
- Multiple Myeloma
- Being tested
- plerixafor GZ316455, Filgrastim
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plerixafor GZ316455Drug
Also called Mozobil
Pharmaceutical form:vial Route of administration: subcutaneous injection
FilgrastimDrug
Pharmaceutical form:vial Route of administration: subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Granulocyte colony-stimulating factor (G-CSF) alone | Active comparator | G-CSF administered up to 8 days Receives: Drug: Filgrastim |
| G-CSF plus plerixafor | Experimental | G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) Receives: Drug: plerixafor GZ316455; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis
Measured: Day 5 to Day 8 of the apheresis/treatment period
Secondary outcomes (7)
Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Measured: Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 6 x10^6 cells/kg CD34+ cells
Measured: Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
Measured: Day 5 to Day 8 of the apheresis/treatment period
Total number of CD34+ cells/kg collected over up to 4 apheresis
Measured: Day 5 to Day 8 of the apheresis/treatment period
The relative increase (ratio) of peripheral blood CD34+ cell count (cells/μL)
Measured: From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only
Number of participants with adverse events
Measured: Up to 68 days
Change from baseline in clinical laboratory measurements
Measured: Up to 68 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221479
- Sponsor's protocol ID
- ACT13710
- Other IDs
- U1111-1152-4403
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02221479
- Acronym / sponsor ID
- ACT13710
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Aug 2014 (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.
Primary Objective:
To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone.
Secondary Objectives:
- To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients.
- To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
- To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.
Detailed description
Total study duration for a participant can be approximately up to 68 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granulocyte colony-stimulating factor (G-CSF) alone | Active comparator | Drug: FilgrastimG-CSF administered up to 8 days |
| G-CSF plus plerixafor | Experimental | Drug: plerixafor GZ316455, Drug: FilgrastimG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 to 75.
- Japanese participants with histological or pathological diagnosis of MM.
- First or second complete response (CR) or partial response (PR).
Key exclusion criteria (33 listed)
- Leukemia participants.
- Myelodysplastic syndrome (MDS) participants.
- Less than 2 weeks since completion of last cycle of chemotherapy.
- Failed previous hematopoietic stem cell (HSC) collections or collection attempts.
- Prior autologous or allogeneic transplant.
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 |
|---|---|---|
| plerixafor GZ316455Also: MozobilPharmaceutical form:vial Route of administration: subcutaneous injection | Drug | G-CSF plus plerixafor |
| FilgrastimPharmaceutical form:vial Route of administration: subcutaneous injection | Drug | G-CSF plus plerixafor, Granulocyte colony-stimulating factor (G-CSF) alone |
Primary outcome
Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis
Time frame: Day 5 to Day 8 of the apheresis/treatment period
7 secondary outcomes
Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 6 x10^6 cells/kg CD34+ cells
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Total number of CD34+ cells/kg collected over up to 4 apheresis
Time frame: Day 5 to Day 8 of the apheresis/treatment period
The relative increase (ratio) of peripheral blood CD34+ cell count (cells/μL)
Time frame: From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only
Number of participants with adverse events
Time frame: Up to 68 days
Change from baseline in clinical laboratory measurements
Time frame: Up to 68 days
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 4 Aug 2015.
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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.
Clinical Sciences & Operations study director
Sanofi
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing plerixafor GZ316455 and Filgrastim in people with Multiple Myeloma, run by Genzyme, a Sanofi Company at 5 sites in Japan.
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 3 inclusion and 33 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 4 Aug 2015. 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 Japan. 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?
Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis (time frame: Day 5 to Day 8 of the apheresis/treatment period). 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 4 Aug 2015.