Phase 2
Completed N=102
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Source: ClinicalTrials.gov NCT00349778 ↗Enrolled (actual)
102
Serious AEs
4.9%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With Pulmonary Toxicity — 32 Participants
Summary
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pulmonary Toxicity |
32 | — |
| SECONDARY Overall Participant Survival (OS) |
52 | — |
| SECONDARY Number of Participants That Relapse After Autologous Transplantation |
66 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed
- Age 18 to 75 years.
- Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
- Patients must have a Karnofsky performance status > 70%.
- Aspartate aminotransferase (AST) must be < 2 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) must be < 2 x ULN
- Total bilirubin < 2 mg/dL.
- Serum creatinine < 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
- Patients must be HIV-negative.
- Patients must provide signed, informed consent.
EXCLUSION CRITERIA
- Severe psychological or medical illness
- Prior autologous hematopoietic cell transplantation
- Pregnant
- Lactating women
- Smoldering multiple myeloma,
- Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study
Data sourced from ClinicalTrials.gov (NCT00349778). 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. Informational only — not medical advice.