Clinical trial NCT00899847: Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
Official title: A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transplantation, Homologous
Transplantation, Autologous
Multiple Myeloma
Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.

Eligibility 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

Primary outcomes:
measure: Incidence of Graft Versus Host Disease (GvHD)
timeFrame: 2 years after the last participant is enrolled.
Secondary outcomes:
measure: Median Time to Engraftment After Auto-PBSC Transplant
timeFrame: 1 month
measure: Median Time to Engraftment After Allo-PBSC Transplant
timeFrame: 1 month
measure: Overall Response Rate (ORR)
timeFrame: 1 year
measure: Complete Response Rate (CRR)
timeFrame: 1 year
measure: Partial Response Rate (PRR)
timeFrame: 1 year
measure: Event-free Survival (EFS)
timeFrame: 2 years after the last participant is enrolled
measure: Overall Survival (OS)
timeFrame: 2 years after the last participant is enrolled
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Wen-Kai Weng
role: PRINCIPAL_INVESTIGATOR
References: