Phase 2
N=63
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Blood Cancer · Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00185614 ↗Enrolled (actual)
63
Serious AEs
100.0%
Results posted
Jan 2018
Primary outcome: Primary: Event-free Survival (EFS) — 0; 24; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous hematopoietic cell transplant (Auto-HCT) (Procedure); Allogeneic hematopoietic cell transplant (Allo-HCT) (Procedure); Cyclophosphamide (Drug); Filgrastim (Drug); Melphalan (Drug); Total body irradiation (TBI) (Radiation); Cyclosporine (CSP) (Procedure); Mycophenolate Mofetil (MMF) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wen-Kai Weng
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival (EFS) |
0; 24; 24 | — |
| SECONDARY Relapse Rate |
2; 29; 31 | — |
| SECONDARY Overall Survival (OS) |
1; 41; 42 | — |
| SECONDARY Acute Graft-vs-Host-Disease (aGvHD) |
7 | — |
| SECONDARY Chronic Graft-vs-Host-Disease (cGvHD) |
30; 8; 21 | — |
Summary
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Eligibility Criteria
PATIENT INCLUSION CRITERIA
- Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease
- Patient has HLA-identical sibling donor
- Age ≤ 70 years
- No prior therapy which would preclude the use of low-dose total body irradiation
- Pathology review and diagnosis confirmation by Stanford University Medical Center
- Karnofsky performance status (KPS) > 70%
- DLCO ≥ 60% predicted
- ALT and AST < 2 x upper limit of normal (ULN)
- Total bilirubin < 2 mg/dL
- Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
- HIV-negative
- Signed informed consent document
PATIENT EXCLUSION CRITERIA
- Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis
- Severe psychological or medical illness
- Prior allogeneic hematopoietic cell transplantation
- Pregnant or lactating
ALLOGENEIC DONOR INCLUSION CRITERIA
- Age ≥ 17
- HIV-seronegative
- Signed informed consent document
ALLOGENEIC 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 (NCT00185614). 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.