Newly Diagnosed Myeloma Patient Above 65 Years OldLATMMNCT01671826
Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years
An observational study of Newly Diagnosed Myeloma Patient Above 65 Years Old, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Myeloma Patient Above 65 Years Old
- How many people
- 55 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2012to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed myeloma patients over 65 years of age and a measurable disease.
Who may be able to join
- newly diagnosed MM,
- age over 65,
- measurable disease
Who cannot join
- Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU
Dijon
CHU
Lille
CHU
Lyon
Institut Paoli Calmette
Marseille
CHU
Nantes
Hôpital Saint Antoine
Paris, 75012
About this study
Official title: Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.
Read the detailed description
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.
- Keywords
- Multiple Myeloma, Autologous Stem Cell Transplantation, Elderly Patients
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| above 65 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Measured: 2 years
Secondary outcomes (3)
Response
Measured: after induction, 3 months post transplant, 2 months post consolidation
Time To Progression
Measured: 2 years
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Newly Diagnosed Myeloma Patient Above 65 Years OldStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Garderet, MD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671826
- Sponsor's protocol ID
- LGT-2012
- Acronym
- LATMM
- Status last verified
- Jun 2016
- First submitted
- 21 Aug 2012
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Garderet L, Beohou E, Caillot D, Stoppa AM, Touzeau C, Chretien ML, Karlin L, Moreau P, Fontan J, Blaise D, Polge E, Gueye MS, Ikhlef S, Marjanovic Z, Labopin M, Mohty M. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016 Nov;101(11):1390-1397. doi: 10.3324/haematol.2016.150334. Epub 2016 Sep 9.
PubMed 27612987
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
- ClinicalTrials.gov ID
- NCT01671826
- Acronym / sponsor ID
- LATMM / LGT-2012
- Keywords
- Multiple Myeloma, Autologous Stem Cell Transplantation, Elderly Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Aug 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.
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.
Detailed description
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| above 65 years old | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed myeloma patients over 65 years of age and a measurable disease.
Key inclusion criteria (3 listed)
- newly diagnosed MM,
- age over 65,
- measurable disease
Key exclusion criteria (1 listed)
- Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free survival
Time frame: 2 years
3 secondary outcomes
Response
Time frame: after induction, 3 months post transplant, 2 months post consolidation
Time To Progression
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 27612987Garderet L, Beohou E, Caillot D, Stoppa AM, Touzeau C, Chretien ML, Karlin L, Moreau P, Fontan J, Blaise D, Polge E, Gueye MS, Ikhlef S, Marjanovic Z, Labopin M, Mohty M. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016 Nov;101(11):1390-1397. doi: 10.3324/haematol.2016.150334. Epub 2016 Sep 9.
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.
Laurent Garderet, MD principal investigator
Assistance Publique
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Myeloma Patient Above 65 Years Old, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Progression Free survival (time frame: 2 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 NCT01671826, 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 Jun 2016.