Multiple MyelomaEarly Phase 1NCT01286675
Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT
A Early Phase 1 study testing Eltrombopag in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Eltrombopag may improve the cell collection available for Autologous Stem Cell Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT will increase the number of blood cells collected and reduce the number of times blood needs to be collected. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Eltrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2018
- Phase
- Early 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma
- Stable or responsive disease after at least 2 cycles of conventional chemotherapy
- Slated to undergo autologous peripheral blood stem cell transplant
- Normal organ and marrow function
Who cannot join
- Myocardial infarction within 6 months of treatment
- Receiving other study agents
- Pregnant or breastfeeding
- Uncontrolled intercurrent illness
- Evidence of active or recent history of thromboembolic disease
- Previous history of primary platelet disorder or bleeding disorder
- History of a different malignancy unless disease free for at least 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Study to Evaluate the Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization and Ex Vivo Colony Proliferative Capacity in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
Eltrombopag may improve the cell collection available for Autologous Stem Cell Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT will increase the number of blood cells collected and reduce the number of times blood needs to be collected. This study will also determine the highest dose of Eltrombopag that can be used without causing serious side effects.
Read the detailed description
Subjects will receive standard treatment for autologous stem cell transplant. Subjects will be assigned to receive no Eltrombopag or one of three dose levels of Eltrombopag. Subjects will receive oral Eltrombopag on days 2-15 of treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Eltrombopag
- Keywords
- ASCT, G-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Also called SB-497-115-GR
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | 0 mg Eltrombopag Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Measured: 1 year
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
Measured: 1 year
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Measured: 1 year
Secondary outcomes (2)
Evaluate the median fold increase in platelet counts at each of the dose levels
Evaluate the median fold increase in platelet counts at each of the dose levels
Measured: 1 year
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionDec 2018
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 Dana-Farber Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Berliner, MD, Dana-Farber Cancer Institute
- Investigators
- Nancy Berliner, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286675
- Sponsor's protocol ID
- 10-346
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2011
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization and Ex Vivo Colony Proliferative Capacity in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01286675
- Acronym / sponsor ID
- 10-346
- Conditions
- Multiple Myeloma
- Keywords
- ASCT, G-CSF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Jan 2011 (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.
Eltrombopag may improve the cell collection available for Autologous Stem Cell Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT will increase the number of blood cells collected and reduce the number of times blood needs to be collected. This study will also determine the highest dose of Eltrombopag that can be used without causing serious side effects.
Detailed description
Subjects will receive standard treatment for autologous stem cell transplant. Subjects will be assigned to receive no Eltrombopag or one of three dose levels of Eltrombopag. Subjects will receive oral Eltrombopag on days 2-15 of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: Eltrombopag0 mg Eltrombopag |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multiple myeloma
- Stable or responsive disease after at least 2 cycles of conventional chemotherapy
- Slated to undergo autologous peripheral blood stem cell transplant
- Normal organ and marrow function
Key exclusion criteria (7 listed)
- Myocardial infarction within 6 months of treatment
- Receiving other study agents
- Pregnant or breastfeeding
- Uncontrolled intercurrent illness
- Evidence of active or recent history of thromboembolic disease
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 |
|---|---|---|
| EltrombopagAlso: SB-497-115-GRoral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15 | Drug | Eltrombopag |
Primary outcome
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Time frame: 1 year
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
Time frame: 1 year
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Time frame: 1 year
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
2 secondary outcomes
Evaluate the median fold increase in platelet counts at each of the dose levels
Time frame: 1 year
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Time frame: 1 year
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 1 Mar 2019.
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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.
Nancy Berliner, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Eltrombopag in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site 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 4 inclusion and 7 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level. (time frame: 1 year). 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 1 Mar 2019.