Refractory Multiple MyelomaPhase 3NCT01301963
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
A Phase 3 study testing plerixafor and filgrastim in people with Refractory Multiple Myeloma, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Refractory Multiple Myeloma
- What is being tested?
- plerixafor and filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MM by International Myeloma Working Group Criteria
- In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood \& Marrow Transplant Research
- Received at least 2 cycles of lenalidomide therapy
- Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
- At least 2 weeks since last exposure to lenalidomide
- Eastern Cooperative Oncology Group performance status of 0 or 1
Show all 12Show fewer
- Prior to the start of mobilization:
- white blood cell count >/= 2.5 x 10^9/L
- absolute neutrophil count >/= 1.2 x 10^9/L
- platelet count >/=100 x 10^9/L
- creatinine clearance >/= 30mL/minute
- If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy
Who cannot join
- Had prior autologous or allogeneic transplantation
- Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
- Failed previous hematopoietic stem cell collections or collection attempts
- Received radiation therapy to the pelvic area
- Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
- Had received experimental therapy within 4 weeks of enrolling in study
- Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
Read the detailed description
PRIMARY OBJECTIVES:
- Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.
SECONDARY OBJECTIVES:
- Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.
II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.
III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.
ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.
After completion of study treatment, patients are followed up at 14 days.
- Conditions
- Refractory Multiple Myeloma
- Being tested
- plerixafor, 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.
plerixaforDrug
Also called AMD 3100, Mozobil
Given SC
filgrastimBiological
Also called G-CSF, Neupogen
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive G-CSF SC QD on days 1-4. Receives: Biological: filgrastim |
| Arm II | Experimental | Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. Receives: Drug: plerixafor; Biological: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
Measured: In =< 2 days of leukaphereses
Secondary outcomes (5)
Percentage of Patients Achieving Target Goal CD34+ Cells Dose
Measured: In =< 5 days of leukaphereses
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.
Measured: By day 1
Compare Days of Apheresis Between Mobilization Groups
Using the Wilcoxon Rand Sum Test
Measured: Day 1
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Measured: Day 1
Compare Need for Remobilization Between Mobilization Groups
Using the Chi-square test or Fisher's exact test, as appropriate.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2013
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hien Duong, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterHillard Lazarus, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301963
- Sponsor's protocol ID
- CASE3A10
- Other IDs
- NCI-2011-00186
- Status last verified
- Jul 2014
- First submitted
- 22 Feb 2011
- Last updated
- 6 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide
- ClinicalTrials.gov ID
- NCT01301963
- Acronym / sponsor ID
- CASE3A10
- Conditions
- Refractory Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
Detailed description
PRIMARY OBJECTIVES:
- Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.
SECONDARY OBJECTIVES:
- Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.
II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.
III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.
ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.
After completion of study treatment, patients are followed up at 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Biological: filgrastimPatients receive G-CSF SC QD on days 1-4. |
| Arm II | Experimental | Drug: plerixafor, Biological: filgrastimPatients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of MM by International Myeloma Working Group Criteria
- In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood \& Marrow Transplant Research
- Received at least 2 cycles of lenalidomide therapy
- Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
- At least 2 weeks since last exposure to lenalidomide
Key exclusion criteria (7 listed)
- Had prior autologous or allogeneic transplantation
- Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
- Failed previous hematopoietic stem cell collections or collection attempts
- Received radiation therapy to the pelvic area
- Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
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: AMD 3100, MozobilGiven SC | Drug | Arm II |
| filgrastimAlso: G-CSF, NeupogenGiven SC | Biological | Arm I, Arm II |
Primary outcome
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
Time frame: In =< 2 days of leukaphereses
5 secondary outcomes
Percentage of Patients Achieving Target Goal CD34+ Cells Dose
Time frame: In =< 5 days of leukaphereses
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
Time frame: By day 1
Compare Days of Apheresis Between Mobilization Groups
Time frame: Day 1
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Time frame: Day 1
Compare Need for Remobilization Between Mobilization Groups
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hien Duong, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Hillard Lazarus, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing plerixafor and filgrastim in people with Refractory Multiple Myeloma, run by Case Comprehensive Cancer Center at 2 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 12 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: stopped early, as of the sponsor's last update on 6 Aug 2014. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg (time frame: In =< 2 days of leukaphereses). 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 6 Aug 2014.