Multiple MyelomaPhase 2/3NCT00714259
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
A Phase 2/3 study testing Fludarabine, Total Body Irradiation and Infusion of Stem Cells in people with Multiple Myeloma and CLL / SLL, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Multiple Myeloma, CLL / SLL, Non Hodgkin's Lymphoma
- What is being tested?
- Fludarabine, Total Body Irradiation and Infusion of Stem Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2013
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II or III non-progressive disease Multiple Myeloma.
- CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
- ≤ 70 years old.
- Eligible and willing HLA matched related donor.
- Bilirubin <2xULN.
- ALT and AST <3xULN.
Show all 14Show fewer
- LVEF > 40%.
- Creatinine Clearance >40mL/min.
- Pulmonary function DLCO corrected to ≥ 70%.
- Minimum performance score of 70%.
- Platelet count >130 x103 micro L.
- LDH ≤1.5xULN.
- No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
- No uncontrolled infections.
Who cannot join
- Age >70 years old.
- Performance status <70%.
- Uncontrolled infections or is HIV positive
- Prior malignancies that are felt to have a <80% probability of being cured.
- Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
- Prior Allograft
- History of rapidly growing disease at diagnosis or at any progression or have MDS.
- No eligible and willing HLA matched donor.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama in Birmingham BMT/CT Program Outpatient Clinic
Birmingham, Alabama, 35249-6979
About this study
Official title: UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Read the detailed description
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.
- Being tested
- Fludarabine, Total Body Irradiation, Infusion of Stem Cells
- Keywords
- Low Grade B Cell Malignancies, nonmyeloablative transplant, allogeneic
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine 30 mg/m2/day x 3 days
Total Body IrradiationRadiation
TBI 200cGy x1 dose on transplant day
Infusion of Stem CellsOther
On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
| Study group | Role | What they receive |
|---|---|---|
| Non Myeloablative Treatment | Other | Non-myeloablative Transplant Conditioning Chemotherapy :
Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. Receives: Drug: Fludarabine; Radiation: Total Body Irradiation; Other: Infusion of Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Free Survival Post Transplant
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Measured: 100 days post transplant
Progressive Free Survival Post Transplant
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Measured: 180 days post transplant
Progressive Free Survival Post Transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Measured: 365 days post transplant
Progression Free Survival Post Transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
Measured: 2 years post transplant
Secondary outcomes (3)
Non-relapse Treatment Related Mortality
Death related to treatment without relapse within 100 days after transplant
Measured: Within 100 days post transplant
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
Measured: Post transplant up to 100 days post transplant
Composite Incidence of Acute and Chronic Graft Versus Host Disease
Measured: Up to 100 days post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Accrual goals could not be met within a timely manner
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 Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Racquel Innis-Shelton, MD, University of Alabama at Birmingham
- Investigators
- William P. Vaughan, MD, Principal investigator, University of Alabama in Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714259
- Sponsor's protocol ID
- F080429003
- Other IDs
- UAB-0775
- Status last verified
- Jun 2017
- First submitted
- 10 Jul 2008
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
- ClinicalTrials.gov ID
- NCT00714259
- Acronym / sponsor ID
- F080429003
- Keywords
- Low Grade B Cell Malignancies, nonmyeloablative transplant, allogeneic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual goals could not be met within a timely manner
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Detailed description
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Myeloablative Treatment | Other | Drug: Fludarabine, Radiation: Total Body Irradiation, Other: Infusion of Stem CellsNon-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Stage II or III non-progressive disease Multiple Myeloma.
- CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
- ≤ 70 years old.
- Eligible and willing HLA matched related donor.
- Bilirubin <2xULN.
Key exclusion criteria (8 listed)
- Age >70 years old.
- Performance status <70%.
- Uncontrolled infections or is HIV positive
- Prior malignancies that are felt to have a <80% probability of being cured.
- Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
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 |
|---|---|---|
| FludarabineFludarabine 30 mg/m2/day x 3 days | Drug | Non Myeloablative Treatment |
| Total Body IrradiationTBI 200cGy x1 dose on transplant day | Radiation | Non Myeloablative Treatment |
| Infusion of Stem CellsOn Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. | Other | Non Myeloablative Treatment |
Primary outcome
Progressive Free Survival Post Transplant
Time frame: 100 days post transplant
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progressive Free Survival Post Transplant
Time frame: 180 days post transplant
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progressive Free Survival Post Transplant
Time frame: 365 days post transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progression Free Survival Post Transplant
Time frame: 2 years post transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
3 secondary outcomes
Non-relapse Treatment Related Mortality
Time frame: Within 100 days post transplant
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Time frame: Post transplant up to 100 days post transplant
Composite Incidence of Acute and Chronic Graft Versus Host Disease
Time frame: Up to 100 days post transplant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William P. Vaughan, MD principal investigator
University of Alabama in Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fludarabine, Total Body Irradiation and Infusion of Stem Cells in people with Multiple Myeloma and CLL / SLL, run by University of Alabama at Birmingham 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 14 inclusion and 8 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 24 Jul 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 May 2017). 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?
Progressive Free Survival Post Transplant (time frame: 100 days post transplant). The study lists 4 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 24 Jul 2017.