Clinical trial · Interventional
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
NCT00349778CI-TRIAL-00030763completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Dose Sequential Therapy
- description
- Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
- interventionNames
- Drug: Cyclophosphamide
- Drug: Etoposide
- Drug: Melphalan
- Drug: Carmustine
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Number of Participants With Pulmonary Toxicity
- timeFrame
- 2 years
- description
- Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.
Secondary outcomes (2)
- measure
- Overall Participant Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChen AI, Negrin RS, McMillan A, Shizuru JA, Johnston LJ, Lowsky R, Miklos DB, Arai S, Weng WK, Laport GG, Stockerl-Goldstein K. Tandem chemo-mobilization followed by high-dose melphalan and carmustine with single autologous hematopoietic cell transplantation for multiple myeloma. Bone Marrow Transplant. 2012 Apr;47(4):516-21. doi: 10.1038/bmt.2011.106. Epub 2011 May 23. PMID 21602899