Edgar Engleman
Mixed Chimera Allo Transplantation in Multiple Myeloma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To determine toxicity and feasibility of mixed chimera allogeneic hematopoietic cell transplants for multiple myeloma; prepare and vaccinate patients with allogenic dendritic cell vaccinations following mixed chimera allogeneic hematopoietic cell transplants
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Procedure: autologous then nonmyeloablative allogeneic transplant
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Multiple myeloma. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease.
- Age less than or equal to 70 years.
- No prior therapy which would preclude the use of low-dose total body irradiation.
- Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis will be excluded from this study.
- Patients must have a Karnofsky performance status greater than 70%.
- DLCO >=60% predicted.
- ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl.
- Serum creatinine < 2.0 or 24-hour creatinine clearance >=60 ml/min.
- Patients must be HIV negative.
- Pregnant or lactating women will not be eligible to participate.
- Patients must provide signed, informed consent.
- Patients must have an HLA-identical sibling donor.
Key Exclusion Criteria:
- Severe psychological or medical illness
- Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study.
Additional Study Details
Official Title:
Mixed Chimera Allogeneic Transplantation with or without Allogeneic Idiotyped Pulsed Dendritic Cells for the Treatment of Multiple MyelomaAnticipated start date:
8/8/2000Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Survival, event-free survival and relapse rate with an intent-to-treat analysis. Results will be compared to allogeneic HCT reported results.
Secondary Outcomes:
- Development of GVHD in vaccinated patients
- Development of GVHD in concurrent myeloma patients receiving allogeneic HCT at our institution who are not candidates for vaccination.
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
60More Information
Secondary ID(s):
- 75190
- BMT109
- NCT00185614
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/15/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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