Multiple MyelomaPhase 2NCT00304720
Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor
A Phase 2 study testing Tacrolimus and MMF in people with Multiple Myeloma and Lymphoma, run by Colorado Blood Cancer Institute at 1 site in United States.
Trial summary
Primary Objective: A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF. B. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma, Acute Myelogenous Leukemia
- What is being tested?
- Tacrolimus and MMF
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to not given
- Phase
- Phase 2
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML, ALL, CML, CLL, myelodysplastic syndrome (MDS), NHL, Hodgkin's disease (HD), or myeloma, who are at significantly higher than usual risk for mortality from conventional myeloablative allogeneic SCT due to age or comorbidities:
- Age ³ 50 years with AML or ALL in complete remission or with <10% blasts in bone marrow
- Age ³ 50 years with MDS or CML.
- Age > 50 years with lymphomas or myeloma, who have failed chemotherapy and are not candidates for an autologous transplant, or who have failed a prior autologous SCT.
- Patients of any age with CLL or low-grade NHL. Patients with CLL and low-grade NHL need to have failed at least first-line treatment, with an alkylating agent, fludarabine or 2-chlorodeoxyadenosine (2-CDA), or anti-CD20 monoclonal antibody rituximab.
- 2. Patients with hematological malignancy relapsed after prior autologous transplantation.
- 3. Patients at high-risk (>60%) of relapsing after autologous transplantation for hematological malignancies may receive allogeneic transplant as "consolidative immunotherapy". Diagnoses include multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's lymphoma, AML, ALL and MDS. Minimal duration between autologous and allogeneic transplants is 4 weeks. 4. Patients of any age with hematologic malignancies treatable by allogeneic SCT, who, because of pre-existing medical conditions, are considered to be at significantly increased risk for transplant toxicity using high-dose transplant regimens. 5. Patients with metastatic renal cell carcinoma. Must have include good performance status (Karnofsky score > 60%), no active brain metastases, life expectancy > 6 months, absence of bulky liver metastases. Patients will be treated on other active disease-specific protocols when available. 6. Patients with other malignant diseases treatable with allogeneic SCT may be eligible for this protocol on a case by case basis, if approved by the principal investigator and the BMT attending physicians group. 7. Available HLA-identical sibling donor, or a phenotypically HLA-matched family member. 8. Age < 70 years.
Who cannot join
- Patients with hematological malignancies eligible for a curative autologous SCT: intermediate- or high-grade NHL with chemo-sensitive first relapse. HD with chemo-sensitive first relapse.
- Age <50 years and eligible for a conventional myeloablative allogeneic SCT.
- Patients with rapidly progressive intermediate or high- grade NHL, unless in minimal disease state.
- Patients with active uncontrolled CNS involvement with malignancy.
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
- Females who are pregnant.
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- Patients who are HIV positive
- Organ dysfunction
- Left ventricle ejection fraction < 35%.
- DLCO <35% of predicted, or receiving continuous supplementary oxygen.
- Liver function tests: total bilirubin >2x the upper limit of normal, and/or transaminases >4x the upper limit of normal.
- Karnofsky score <50 for patients < 60 years, or <70 for patients aged 60 - 69 years (see appendix B).
- Creatinine clearance < 60 ml/min.
- Patients with hypertension that is poorly controlled on antihypertensive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218
Peter A McSweeney, MD, 303-336-2184, Peter.McSweeney@usoncology.com
Juli B Murphy, 303-285-5087, Juli.Murphy@usoncology.com
About this study
Official title: Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
Primary Objective:
- To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF.
- To evaluate the incidence of grade II-IV GVHD associated with this treatment.
Read the detailed description
Conditioning regimen:
- Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
- Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration.
Immunosuppression:
Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).
- Conditions
- Multiple Myeloma, Lymphoma, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome
- Being tested
- Tacrolimus and MMF
- Keywords
- Lymphoma, Leukemia
- Medical subject headings
- Multiple Myeloma, Lymphoma, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus and MMFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoints are day 100 mortality and acute GVHD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startMar 2004
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Blood Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Peter A McSweeney, MD, Principal investigator, Colorado Blood Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304720
- Sponsor's protocol ID
- RMBMT-124-A
- Status last verified
- Mar 2004
- First submitted
- 17 Mar 2006
- Last updated
- 8 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
- ClinicalTrials.gov ID
- NCT00304720
- Acronym / sponsor ID
- RMBMT-124-A
- Conditions
- Multiple Myeloma, Lymphoma, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome
- Keywords
- Lymphoma, Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Colorado Blood Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2004
- First posted
- 20 Mar 2006 (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.
Primary Objective:
- To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF.
- To evaluate the incidence of grade II-IV GVHD associated with this treatment.
Detailed description
Conditioning regimen:
- Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
- Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration.
Immunosuppression:
Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with AML, ALL, CML, CLL, myelodysplastic syndrome (MDS), NHL, Hodgkin's disease (HD), or myeloma, who are at significantly higher than usual risk for mortality from conventional myeloablative allogeneic SCT due to age or comorbidities:
- Age ³ 50 years with AML or ALL in complete remission or with <10% blasts in bone marrow
- Age ³ 50 years with MDS or CML.
- Age > 50 years with lymphomas or myeloma, who have failed chemotherapy and are not candidates for an autologous transplant, or who have failed a prior autologous SCT.
- Patients of any age with CLL or low-grade NHL. Patients with CLL and low-grade NHL need to have failed at least first-line treatment, with an alkylating agent, fludarabine or 2-chlorodeoxyadenosine (2-CDA), or anti-CD20 monoclonal antibody rituximab.
Key exclusion criteria (14 listed)
- Patients with hematological malignancies eligible for a curative autologous SCT: intermediate- or high-grade NHL with chemo-sensitive first relapse. HD with chemo-sensitive first relapse.
- Age <50 years and eligible for a conventional myeloablative allogeneic SCT.
- Patients with rapidly progressive intermediate or high- grade NHL, unless in minimal disease state.
- Patients with active uncontrolled CNS involvement with malignancy.
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
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 |
|---|---|---|
| Tacrolimus and MMF | Drug | – |
Primary outcome
The main endpoints are day 100 mortality and acute GVHD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
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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.
Rocky Mountain Blood and Marrow Transplant Program
Denver, United States
Peter A McSweeney, MD principal investigator
Colorado Blood Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus and MMF in people with Multiple Myeloma and Lymphoma, run by Colorado Blood Cancer Institute 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 7 inclusion and 14 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 8 Feb 2008. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main endpoints are day 100 mortality and acute GVHD.. 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 8 Feb 2008.