Ph II of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00899847
First received: May 8, 2009
Last updated: October 29, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Incidence of Graft-versus-host disease [ Time Frame: wo years after the last participant is enrolled. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Ciclofosfamida
  • Ciclofosfamide
  • Claphene
  • CP monohydrate
  • CPM
  • CTX
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • granulocyte colony-stimulating factor
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Drug: melphalan
Given IV
Other Names:
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
  • L-Sarcolysin phenylalanine mustard
  • L-sarcolysine
  • phenylalanine mustard
Procedure: peripheral blood stem cell transplantation
Undergo allogeneic SCT
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation
  • peripheral blood stem cell
Radiation: total nodal irradiation
Undergo TLI
Other Names:
  • TLI
  • total lymphoid irradiation
Biological: anti-thymocyte globulin
Given IV
Other Names:
  • ATG
  • lymphocyte immune globulin
Drug: cyclosporine
Given PO
Other Names:
  • ciclosporin
  • CsA
  • cyclosporin
  • cyclosporin A
  • CYSP
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899847

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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: October 29, 2013
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 July 22, 2014