Multiple MyelomaNCT02184897
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
A study testing lenograstim 10 microgram/kg/day in people with Multiple Myeloma, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- lenograstim 10 microgram/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: above 17 years, below 65 years old
- informed consent
- ECOG 0-1
- autologous stem cell transplant candidate among patients with multiple myeloma
Who cannot join
- prior history of hematopoetic stem cell transplantation
- history of failure to mobilize hematopoietic stem cells
- history of G-CSF administration within 2 weeks before enrollment to this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
Asan Medical Center
Seoul, 1387-736
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.
- Conditions
- Multiple Myeloma
- Being tested
- lenograstim 10 microgram/kg/day
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenograstim 10 microgram/kg/dayDrug
| Study group | Role | What they receive |
|---|---|---|
| AM group | Active comparator | Lenograstim is administered at 8 am and apheresis is started at 10 am on D4. Receives: Drug: lenograstim 10 microgram/kg/day |
| PM group | Experimental | Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5 Receives: Drug: lenograstim 10 microgram/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic data of lenograstim
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
Measured: on day 1 of apheresis
Secondary outcomes (3)
pharmacodynamic data: CD34+ cell count by flow cytometry
Measured: on day 1 of apheresis
pharmacodynamic data: absolute neutrophil count
Measured: on day 1 of apheresis
pharmacodynamic data: hematopoietic progenitor cells (HPC)
Measured: on day 1 of apheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Asan Medical CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184897
- Sponsor's protocol ID
- AMC_MM01
- Status last verified
- Jul 2016
- First submitted
- 22 Jun 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02184897
- Acronym / sponsor ID
- AMC_MM01
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jul 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.
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM group | Active comparator | Drug: lenograstim 10 microgram/kg/dayLenograstim is administered at 8 am and apheresis is started at 10 am on D4. |
| PM group | Experimental | Drug: lenograstim 10 microgram/kg/dayLenograstim is administered at 6 pm and apheresis is started at 8 am on D5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: above 17 years, below 65 years old
- informed consent
- ECOG 0-1
- autologous stem cell transplant candidate among patients with multiple myeloma
Key exclusion criteria (3 listed)
- prior history of hematopoetic stem cell transplantation
- history of failure to mobilize hematopoietic stem cells
- history of G-CSF administration within 2 weeks before enrollment to this study
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 |
|---|---|---|
| lenograstim 10 microgram/kg/day | Drug | AM group, PM group |
Primary outcome
pharmacokinetic data of lenograstim
Time frame: on day 1 of apheresis
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
3 secondary outcomes
pharmacodynamic data: CD34+ cell count by flow cytometry
Time frame: on day 1 of apheresis
pharmacodynamic data: absolute neutrophil count
Time frame: on day 1 of apheresis
pharmacodynamic data: hematopoietic progenitor cells (HPC)
Time frame: on day 1 of apheresis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lenograstim 10 microgram/kg/day in people with Multiple Myeloma, run by Asan Medical Center at 2 sites in South Korea.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
Are results available for this study?
Results are not available in the source record.
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?
pharmacokinetic data of lenograstim (time frame: on day 1 of apheresis). 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 26 Jul 2016.