Multiple MyelomaNCT00741780
Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).
An observational study of Multiple Myeloma and Autologous Transplantation, run by Genzyme, a Sanofi Company.
Trial summary
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma, Autologous Transplantation
- What is being tested?
- plerixafor and granulocyte colony-stimulating factor (G-CSF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jul 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the AMD3100-3102 study (NCT00103662) who received a at least one dose of study treatment (plerixafor or placebo).
Who may be able to join
- All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)
Who cannot join
- No Exclusion Criteria
About this study
Official title: Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).
Read the detailed description
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF [NCT00103662]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).
- Conditions
- Multiple Myeloma, Autologous Transplantation
- Being tested
- Placebo, plerixafor, granulocyte colony-stimulating factor (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.
PlaceboDrug
plerixaforDrug
Also called Mozobil, AMD3100
granulocyte colony-stimulating factor (G-CSF)Drug
| Study group | Role | What they receive |
|---|---|---|
| G-CSF plus plerixafor | Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis. Receives: Drug: plerixafor; Drug: granulocyte colony-stimulating factor (G-CSF) | |
| G-CSF plus placebo | Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis. Receives: Drug: Placebo; Drug: granulocyte colony-stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741780
- Sponsor's protocol ID
- AMD31003102LTF
- Status last verified
- Mar 2015
- First submitted
- 22 Aug 2008
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.
PubMed 29410180
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
- ClinicalTrials.gov ID
- NCT00741780
- Acronym / sponsor ID
- AMD31003102LTF
- Conditions
- Multiple Myeloma, Autologous Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Aug 2008 (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.
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).
Detailed description
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF [NCT00103662]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF plus plerixafor | – | Drug: plerixafor, Drug: granulocyte colony-stimulating factor (G-CSF)Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis. |
| G-CSF plus placebo | – | Drug: Placebo, Drug: granulocyte colony-stimulating factor (G-CSF)Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the AMD3100-3102 study (NCT00103662) who received a at least one dose of study treatment (plerixafor or placebo).
Key inclusion criteria (1 listed)
- All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)
Key exclusion criteria (1 listed)
- No Exclusion Criteria
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 |
|---|---|---|
| Placebo | Drug | G-CSF plus placebo |
| plerixaforAlso: Mozobil, AMD3100 | Drug | G-CSF plus plerixafor |
| granulocyte colony-stimulating factor (G-CSF) | Drug | G-CSF plus placebo, G-CSF plus plerixafor |
Primary outcome
Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662)
Time frame: 5 years
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 24 Mar 2015.
- Derived from this study: PubMed 29410180Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Medical Monitor study director
Genzyme, a Sanofi Company
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Autologous Transplantation, run by Genzyme, a Sanofi Company.
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 1 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741780, which also lists 1 linked publication.
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 24 Mar 2015.