drugset / Trial / NCT00083551
UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
Timeline
- Start
- 1998-08
- Primary completion
- 2014-08
- Completion
- 2014-08
Publications
- Results Barlogie B, Tricot G, Anaissie E, Shaughnessy J, Rasmussen E, van Rhee F, Fassas A, Zangari M, Hollmig K, Pineda-Roman M, Lee C, Talamo G, Thertulien R, Kiwan E, Krishna S, Fox M, Crowley J. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med. 2006 Mar 9;354(10):1021-30. doi: 10.1056/NEJMoa053583.
- Al Hadidi S, Ababneh OE, Schinke CD, Thanendrarajan S, Siegel ER, Bailey C, Smith R, Panozzo SB, Zangari M, Tricot G, Shaughnessy JD Jr, Zhan F, Sawyer J, Barlogie B, van Rhee F. Long-Term Follow-Up of Patients With Multiple Myeloma Treated on Earlier Total Therapy Protocols: A Secondary Analysis of 3 Clinical Trials. JAMA Oncol. 2025 Aug 1;11(8):910-915. doi: 10.1001/jamaoncol.2025.1394.
- Vatsveen TK, Sponaas AM, Tian E, Zhang Q, Misund K, Sundan A, Borset M, Waage A, Brede G. Erythropoietin (EPO)-receptor signaling induces cell death of primary myeloma cells in vitro. J Hematol Oncol. 2016 Aug 31;9(1):75. doi: 10.1186/s13045-016-0306-x.
- Usmani SZ, Heuck C, Mitchell A, Szymonifka J, Nair B, Hoering A, Alsayed Y, Waheed S, Haider S, Restrepo A, Van Rhee F, Crowley J, Barlogie B. Extramedullary disease portends poor prognosis in multiple myeloma and is over-represented in high-risk disease even in the era of novel agents. Haematologica. 2012 Nov;97(11):1761-7. doi: 10.3324/haematol.2012.065698. Epub 2012 Jun 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Thalidomide | Other / unclassified | 50 mg | Oral |
| Comparator | Cisplatin | Other / unclassified | 7.5 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 10 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 15 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 400 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 2000 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 400 mg/m2 | — |
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Comparator | Etoposide | Small molecule | 200 mg/m2 | — |
| Comparator | Melphalan | Small molecule | — | — |
| Comparator | Vincristine | Small molecule | — | Intravenous |
| Comparator | carmustine | Small molecule | 300 mg/m2 | — |
| Comparator | filgrastim | Protein / enzyme biologic | 10 ug/kg | — |
| Comparator | interferon alfa-2b | Protein / enzyme biologic | 3 iu | — |
| Comparator | sargramostim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |