Multiple MyelomaNCT02786511
Longterm Follow-up of Subjects Treated With bb2121
An observational study of Multiple Myeloma, run by Celgene at 9 sites in United States.
Trial summary
This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Safety and efficacy assessments
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Apr 2016to 11 Oct 2019
- 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: Subjects with multiple myeloma who were administered bb2121 in Study CRB-401
Who may be able to join
- Provision of written informed consent for this study by subjects
- Were administered bb2121 in the parent clinical study
- Able to comply with the study requirements
Who cannot join
- Subject has disease progression AND subject has undetectable VCN (<0.0003 vector copies per diploid genome) in peripheral blood cells for 2 consecutive measurements at least 1 month apart, at least 12 months after drug product infusion
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
National Cancer Institute
Bethesda, Maryland, 20892
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02144
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Mount Sinai Medical Center
New York, New York, 10029
Stanford Cancer Center
Palo Alto, California, 94305
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.
bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.
After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.
Read the detailed description
The LTF-305 study has completed enrollment and is scheduled to be closed. All patients participating in this study have discontinued from follow-up or have been transferred into the GC-LTFU-001 study for further observation (similar to time frames established in the LTF-305).
- Conditions
- Multiple Myeloma
- Being tested
- Safety and efficacy assessments
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety and efficacy assessmentsDrug
Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant
| Study group | Role | What they receive |
|---|---|---|
| Subjects with multiple myeloma | Subjects treated with ex vivo gene therapy in a bluebird bio sponsored trial who agree to participate in this study. Receives: Drug: Safety and efficacy assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 15 years post-drug product infusion
Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product
Measured: 15 years post-drug product infusion
Monitoring for all Serious Adverse Events including any new malignancy or new diagnosis of a neurologic, rheumatologic, or hematologic disorder that is clinically significant
Measured: 5 years post-drug product infusion
Monitoring for Multiple Myeloma-specific response according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Measured: 5-15 years post-drug product infusion
Progression Free Survival
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Measured: 5-15 years post-drug product infusion
Monitoring for Vector Copy Number (VCN)
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Measured: 5-15 years post-drug product infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start28 Apr 2016
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
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 CelgeneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen Hege, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786511
- Sponsor's protocol ID
- LTF-305
- Status last verified
- Jan 2020
- First submitted
- 26 May 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Follow-up of Subjects Treated With bb2121
- ClinicalTrials.gov ID
- NCT02786511
- Acronym / sponsor ID
- LTF-305
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 1 Jun 2016 (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 multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.
bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.
After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.
Detailed description
The LTF-305 study has completed enrollment and is scheduled to be closed. All patients participating in this study have discontinued from follow-up or have been transferred into the GC-LTFU-001 study for further observation (similar to time frames established in the LTF-305).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with multiple myeloma | – | Drug: Safety and efficacy assessmentsSubjects treated with ex vivo gene therapy in a bluebird bio sponsored trial who agree to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with multiple myeloma who were administered bb2121 in Study CRB-401
Key inclusion criteria (3 listed)
- Provision of written informed consent for this study by subjects
- Were administered bb2121 in the parent clinical study
- Able to comply with the study requirements
Key exclusion criteria (1 listed)
- Subject has disease progression AND subject has undetectable VCN (<0.0003 vector copies per diploid genome) in peripheral blood cells for 2 consecutive measurements at least 1 month apart, at least 12 months after drug product infusion
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 |
|---|---|---|
| Safety and efficacy assessmentsVector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant | Drug | Subjects with multiple myeloma |
Primary outcome
Overall survival
Time frame: 15 years post-drug product infusion
Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product
Time frame: 15 years post-drug product infusion
Monitoring for all Serious Adverse Events including any new malignancy or new diagnosis of a neurologic, rheumatologic, or hematologic disorder that is clinically significant
Time frame: 5 years post-drug product infusion
Monitoring for Multiple Myeloma-specific response according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Time frame: 5-15 years post-drug product infusion
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Progression Free Survival
Time frame: 5-15 years post-drug product infusion
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
Monitoring for Vector Copy Number (VCN)
Time frame: 5-15 years post-drug product infusion
Subjects without disease progression will be evaluated for at least 5 years post-drug product infusion if VCN is undetectable, and up to 15 years post-drug product infusion if VCN remains detectable.
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 22 Jan 2020.
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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.
Kristen Hege study director
Celgene Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 9 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 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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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?
Overall survival (time frame: 15 years post-drug product infusion). The study lists 6 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 22 Jan 2020.