Myeloma, Plasma-CellPhase 2NCT00146055
Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
A Phase 2 study testing Reduced intensity conditioning with allogeneic transplant in people with Myeloma, Plasma-Cell and Lymphoma, Malignant, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders
- What is being tested?
- Reduced intensity conditioning with allogeneic transplant
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Oct 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be a candidate for unrelated donor stem cell transplantation and the donor and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the following histologically confirmed diagnosis :
- Patients with previously treated AML (M0 - M7 by FAB classification)
- who are in not in complete remission (CR).
- who are in second or later CR.
- who have 5-30% persistent blasts in bone marrow following induction or salvage chemotherapy.
- who have high-risk feature in first complete remission e.g. presence of Philadelphia chromosome or non-core-binding factor type of chromosomal abnormalities.
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- Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who are transfusion-dependent.
- Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic phase
- Patients with acute lymphoblastic leukemia
- who are in first complete remission and have high risk disease [Ph' or t (4; 11) , WBC> 30,000, > 4 weeks to achieve CR].
- who are in second or greater CR.
- who did not achieve a CR following induction or salvage therapy.
- Patients with Hodgkin's or non-Hodgkin's lymphoma who are not curable with conventional chemotherapy and do not have any tumor larger than 5 centimeters in diameter.
- Patients with myeloma or plasma cell neoplasms who are :
- stage III at presentation.
- stage I-II at presentation but were not responding or progressed after first line therapy.
- Patient with chronic lymphocytic leukemia or Waldenström's macroglobulinemia who progressed after first-line therapy.
- Patients with MDS or myeloproliferative disorders who had history of life-threatening complications related to thrombosis, hemorrhagic diathesis or intractable hypercatabolic state (fever cachexia).
Who cannot join
- Cardiac disease of symptomatic nature; < 25% ejection fraction.
- Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min. (Corrected for age)
- Severe pulmonary disease < 60% normal (FEV1 \& FVC).
- Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected for age.
- Karnofsky performance status of < 60%.
- Patients with evidence of HIV infection by western blot.
- Any conditions, in the opinion of the transplant team such as substance abuse, or severe personality disorder that would keep the patients from complying with the needs of the protocol and would markedly increase the morbidity and mortality from the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.
Read the detailed description
Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a current treatment approach. Chemotherapeutic drugs and radiation are given in higher doses to increase their effectiveness. High-dose chemotherapy and radiation therapy generally affect cells that are dividing. They are used to treat cancer because cancer cells divide more often than most other cells. High-dose treatment severely damages the patient's bone marrow so that the patient no longer is able to produce needed blood cells. Peripheral stem cell transplantation allows stem cells that were damaged by treatment to be replaced with healthy stem cells that can produce the blood cells the patient needs. Patients experience a number of complications after transplantation. Some are temporary and relatively minor; yet others can be life threatening. Many doctors consider high-dose chemotherapy, by itself or with radiation, and bone marrow or stem cell transplantation as the best available treatment option for diseases under specific circumstances. However, this study will explore whether a less-intensive preparative therapy before the peripheral stem cell transplantation will prove to be safer, have less side effects, and be an effective treatment for certain diseases.
- Conditions
- Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom's Macroglobulinemia
- Being tested
- Reduced intensity conditioning with allogeneic transplant
- Medical subject headings
- Multiple Myeloma, Lymphoma, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced intensity conditioning with allogeneic transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
- To evaluate the engraftment, and chimerism.
- To estimate the rate of acute GVHD, relapse and survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMar 2000
- Primary completionNov 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma, Plasma-CellStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John E. Levine, MS MD, Principal investigator, The Univeristy of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146055
- Sponsor's protocol ID
- UMCC 9970
- Status last verified
- Aug 2012
- First submitted
- 1 Sep 2005
- Last updated
- 9 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT00146055
- Acronym / sponsor ID
- UMCC 9970
- Conditions
- Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom's Macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Nov 2004 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Sep 2005 (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.
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.
Detailed description
Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a current treatment approach. Chemotherapeutic drugs and radiation are given in higher doses to increase their effectiveness. High-dose chemotherapy and radiation therapy generally affect cells that are dividing. They are used to treat cancer because cancer cells divide more often than most other cells. High-dose treatment severely damages the patient's bone marrow so that the patient no longer is able to produce needed blood cells. Peripheral stem cell transplantation allows stem cells that were damaged by treatment to be replaced with healthy stem cells that can produce the blood cells the patient needs. Patients experience a number of complications after transplantation. Some are temporary and relatively minor; yet others can be life threatening. Many doctors consider high-dose chemotherapy, by itself or with radiation, and bone marrow or stem cell transplantation as the best available treatment option for diseases under specific circumstances. However, this study will explore whether a less-intensive preparative therapy before the peripheral stem cell transplantation will prove to be safer, have less side effects, and be an effective treatment for certain diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must be a candidate for unrelated donor stem cell transplantation and the donor and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the following histologically confirmed diagnosis :
- Patients with previously treated AML (M0 - M7 by FAB classification)
- Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who are transfusion-dependent.
- Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic phase
- Patients with acute lymphoblastic leukemia
Key exclusion criteria (7 listed)
- Cardiac disease of symptomatic nature; < 25% ejection fraction.
- Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min. (Corrected for age)
- Severe pulmonary disease < 60% normal (FEV1 \& FVC).
- Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected for age.
- Karnofsky performance status of < 60%.
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 |
|---|---|---|
| Reduced intensity conditioning with allogeneic transplant | Procedure or surgery | – |
Primary outcome
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
- To evaluate the engraftment, and chimerism.
- To estimate the rate of acute GVHD, relapse and survival.
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 9 Aug 2012.
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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.
John E. Levine, MS MD principal investigator
The Univeristy of Michigan
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 Reduced intensity conditioning with allogeneic transplant in people with Myeloma, Plasma-Cell and Lymphoma, Malignant, run by University of Michigan Rogel Cancer Center 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 18 inclusion and 7 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 9 Aug 2012. 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?
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?
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.. The study lists 3 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 9 Aug 2012.