Multiple MyelomaPhase 2NCT01753453
An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
A Phase 2 study testing Plerixafor and Granulocyte-colony stimulating factor (G-CSF) in people with Multiple Myeloma, run by Sanofi at 5 sites in 4 countries.
Trial summary
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Plerixafor and Granulocyte-colony stimulating factor (G-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jun 2013to Sep 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
- Patients with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers.
Who cannot join
- Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
- Had prior allogeneic or autologous transplantation.
- Less than 3 to 6 weeks since last anti-cancer therapy.
- Chemotherapy for mobilization is not allowed.
- Has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF.
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- Was treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
- Has previously received plerixafor.
- Is known to be HIV positive.
- Has active hepatitis B or hepatitis C.
- Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
- Has hypercalcaemia as evidenced by >1 mg/dL above upper limit of normal (ULN).
- Previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
- Has central nervous system involvement including brain metastases or leptomeningeal disease.
- Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality.
- Has co-morbid condition(s), which may render the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol.
- Has a white blood cell (WBC) count <2.5 x 10^9/L.
- Has an absolute neutrophil count (ANC) <1.5 x 10^9/L.
- Has a platelet count <100 x 10^9/L.
- Has an estimated creatine clearance ≤50 mL/min.
- Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x ULN.
- Does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation.
- Pregnant or breastfeeding women.
- Does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Investigational Site Number 752001
Stockholm, 14186
Investigational Site Number 752002
Umeå, 901 85
About this study
Official title: A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-pegylated G-CSF Mobilized Patients and in Non-pegylated G-CSF Alone Mobilized Patients
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- Plerixafor, Granulocyte-colony stimulating factor (G-CSF)
- Keywords
- Hematopoietic stem cell transplantation, Tumour cell mobilization
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil,AMD3100
240mcg/kg, solution, subcutaneous injection
Granulocyte-colony stimulating factor (G-CSF)Drug
10 mcg/kg, solution, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| G-CSF alone | Active comparator | Patients will receive G-CSF for 5 consecutive days Receives: Drug: Granulocyte-colony stimulating factor (G-CSF) |
| G-CSF plus plerixafor | Experimental | Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF Receives: Drug: Plerixafor; Drug: Granulocyte-colony stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
Peripheral blood parameters
Measured: Day 1 to Day 8 of the apheresis/treatment period
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
Peripheral blood parameters
Measured: Day 5 to Day 8 of the apheresis/treatment period
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
Peripheral blood parameters
Measured: Day 5 to Day 8 of the apheresis/treatment period
The change in tumor cell mobilization(TCM) in the peripheral blood
Peripheral blood parameters
Measured: Day 4 pre-G-CSF to Day 5 pre-G-CSF
The number of myeloma tumor cells per patient at each apheresis
Apheresis product parameters
Measured: Day 1 to Day 8 of the apheresis/treatment period
The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product
Apheresis product parameters
Measured: Day 5 to Day 8 of the apheresis/treatment period
Secondary outcomes (3)
CD34+ stem cell yield in the apheresis product
Measured: Day 1 to Day 8 of the apheresis/treatment period
The number of patients that proceed to transplantation
Measured: Up to 2 months after final apheresis
Overall survival
Measured: Day 100 post transplant and up to 2 years post first-G-CSF dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionSep 2016
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753453
- Sponsor's protocol ID
- ARD12858
- Other IDs
- MOZ23510, 2011-004783-30
- Status last verified
- Feb 2021
- First submitted
- 17 Dec 2012
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-pegylated G-CSF Mobilized Patients and in Non-pegylated G-CSF Alone Mobilized Patients
- ClinicalTrials.gov ID
- NCT01753453
- Acronym / sponsor ID
- ARD12858
- Conditions
- Multiple Myeloma
- Keywords
- Hematopoietic stem cell transplantation, Tumour cell mobilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Dec 2012 (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.
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF alone | Active comparator | Drug: Granulocyte-colony stimulating factor (G-CSF)Patients will receive G-CSF for 5 consecutive days |
| G-CSF plus plerixafor | Experimental | Drug: Plerixafor, Drug: Granulocyte-colony stimulating factor (G-CSF)Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers.
Key exclusion criteria (24 listed)
- Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
- Had prior allogeneic or autologous transplantation.
- Less than 3 to 6 weeks since last anti-cancer therapy.
- Chemotherapy for mobilization is not allowed.
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 |
|---|---|---|
| PlerixaforAlso: Mozobil,AMD3100240mcg/kg, solution, subcutaneous injection | Drug | G-CSF plus plerixafor |
| Granulocyte-colony stimulating factor (G-CSF)10 mcg/kg, solution, subcutaneous injection | Drug | G-CSF alone, G-CSF plus plerixafor |
Primary outcome
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
Time frame: Day 1 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The change in tumor cell mobilization(TCM) in the peripheral blood
Time frame: Day 4 pre-G-CSF to Day 5 pre-G-CSF
Peripheral blood parameters
The number of myeloma tumor cells per patient at each apheresis
Time frame: Day 1 to Day 8 of the apheresis/treatment period
Apheresis product parameters
The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product
Time frame: Day 5 to Day 8 of the apheresis/treatment period
Apheresis product parameters
3 secondary outcomes
CD34+ stem cell yield in the apheresis product
Time frame: Day 1 to Day 8 of the apheresis/treatment period
The number of patients that proceed to transplantation
Time frame: Up to 2 months after final apheresis
Overall survival
Time frame: Day 100 post transplant and up to 2 years post first-G-CSF dose
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 23 Feb 2021.
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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 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor and Granulocyte-colony stimulating factor (G-CSF) in people with Multiple Myeloma, run by Sanofi at 5 sites in 4 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 1 inclusion and 24 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 23 Feb 2021. 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 Sweden, Belgium, Estonia, Lithuania. 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?
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells (time frame: Day 1 to Day 8 of the apheresis/treatment period). The study lists 6 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 23 Feb 2021.