Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Acetaminophen; Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Cyclosporins; Diphenhydramine; Hydrocortisone; Lenograstim; Mechlorethamine; Melphalan; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Promethazine; Thymoglobulin

Criteria

PARTICIPANT INCLUSION CRITERIA

• 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.

• Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center.

• 18 to ≤ 75 years of age

• Karnofsky Performance Status > 70%.

• Corrected Carbon monoxide diffusing capacity (Dlco) > 60%

• Left ventricle ejection fraction (LVEF) > 50%.

• Alanine aminotransferase (ALT) ≤ 2 x normal

• Aspartate aminotransferase (AST) ≤ 2 x normal

• Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease.

• Estimated creatinine clearance > 50 mL/min.

• Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1).

• Signed informed consent.

DONOR INCLUSION CRITERIA

• At least 17 years of age

• HIV-seronegative

• Must be capable of giving signed, informed consent

• No contraindication to the administration of filgrastim

• Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate

PARTICIPANT EXCLUSION CRITERIA

• Prior allogeneic hematopoietic cell transplantation

• Uncontrolled active infection

• Uncontrolled congestive heart failure or angina

• HIV-positive

• Pregnant or nursing

DONOR EXCLUSION CRITERIA

• Serious medical or psychological illness

• Pregnant or lactating

• Prior malignancies within the last 5 years except for non-melanoma skin cancers