Ph II of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
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Purpose
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Transplantation, Homologous Transplantation, Autologous Multiple Myeloma Blood and Marrow Transplant (BMT) |
Procedure: Autologous/Allogeneic HCT Drug: cyclophosphamide Biological: filgrastim Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: total nodal irradiation Biological: anti-thymocyte globulin Drug: cyclosporine Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients |
- Incidence of Graft-versus-host disease [ Time Frame: wo years after the last participant is enrolled. ] [ Designated as safety issue: Yes ]
- Relapse, Event free survival, Overall survival [ Time Frame: Two years after the study closes to accrual ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 43 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment (autologous-allogeneic tandem hematopoietic SCT) |
Procedure: Autologous/Allogeneic HCT
Undergo autologous hematopoietic SCT
Drug: cyclophosphamide
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: melphalan
Given IV
Other Names:
Procedure: peripheral blood stem cell transplantation
Undergo allogeneic SCT
Other Names:
Radiation: total nodal irradiation
Undergo TLI
Other Names:
Biological: anti-thymocyte globulin
Given IV
Other Names:
Drug: cyclosporine
Given PO
Other Names:
Drug: mycophenolate mofetil
Given PO
Other Name: MMF
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo allogeneic SCT
Other: laboratory biomarker analysis
Correlative studies
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
3.1.1 Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included.
3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
3.1.3 Age > 18 years and <= 75 years.
3.1.4 Karnofsky Performance Status > 70%.
3.1.5 Corrected DLCO > 60%
3.1.6 Left ventricle ejection fraction (LVEF) > 50%.
3.1.7 ALT and AST must be <= 2X normal. Total bilirubin <= 2 mg/dL unless hemolysis or Gilbert's disease.
3.1.8 Estimated creatinine clearance > 50 ml/min.
3.1.9 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.
3.1.10 Signed informed consent.
3.3 Donor Evaluation Inclusion Criteria
3.3.1 Age >=17.
3.3.2 HIV seronegative
3.3.3 Donor must be capable of giving signed, informed consent
3.3.4 No contraindication to the administration of G-CSF
3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate.
Exclusion Criteria:
3.2.1 Prior allogeneic hematopoietic cell transplantation.
3.2.2 Uncontrolled active infection.
3.2.4 Uncontrolled congestive heart failure or angina.
3.2.5 Pregnancy or nursing patients will be excluded from the study.
3.2.6 Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.
3.4 Donor Evaluation Exclusion Criteria
3.4.1 Serious medical or psychological illness.
3.4.2 Pregnant or lactating women are not eligible
3.4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Wen-Kai Weng | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00899847 History of Changes |
| Other Study ID Numbers: | BMT201, SU-04142009-2259 |
| Study First Received: | May 8, 2009 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Antilymphocyte Serum |
Cyclophosphamide Cyclosporins Cyclosporine Melphalan Mycophenolate mofetil Immunoglobulins Lenograstim Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 23, 2013