Phase 2
N=9
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
Transplantation, Homologous · Transplantation, Autologous · Multiple Myeloma · Blood and Marrow Transplant (BMT)
Bottom Line
View on ClinicalTrials.gov: NCT00899847 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Oct 2017
Primary outcome: Primary: Incidence of Graft Versus Host Disease (GvHD) — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous peripheral blood stem cells (auto-PBSC) transplantation (Procedure); Allogeneic peripheral blood stem cells (allo-PBSC) transplantation (Procedure); Filgrastim (Drug); Cyclophosphamide (Drug); Melphalan (Drug); Cyclosporine (Drug); Total lymphoid irradiation (Radiation); Rabbit anti-thymocyte globulin (Biological); Mycophenolate Mofetil 250mg (Drug); Solumedrol (Drug); Diphenhydramine (Drug); Acetaminophen (Drug); Hydrocortisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Graft Versus Host Disease (GvHD) |
1 | — |
| SECONDARY Median Time to Engraftment After Auto-PBSC Transplant |
11; 15 | — |
| SECONDARY Median Time to Engraftment After Allo-PBSC Transplant |
24; 10 | — |
| SECONDARY Overall Response Rate (ORR) |
7 | — |
| SECONDARY Complete Response Rate (CRR) |
3 | — |
| SECONDARY Partial Response Rate (PRR) |
4 | — |
| SECONDARY Event-free Survival (EFS) |
44 | — |
| SECONDARY Overall Survival (OS) |
67 | — |
Summary
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
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
Data sourced from ClinicalTrials.gov (NCT00899847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.