Phase III Clinical Trial of Thalidomide Plus Dexamethasone Compared With Dexamethasone Alone in Newly Diagnosed Multiple Myeloma: A Clinical Trial Coordinated by the Eastern Cooperative Oncology Group
Abstract
Purpose: To determine if thalidomide plus dexamethasone yields superior response rates compared with dexamethasone alone as induction therapy for newly diagnosed multiple myeloma. Patients and Methods: Patients were randomly assigned to receive thalidomide plus dexamethasone or dexamethasone alone. Patients in arm A received thalidomide 200 mg orally for 4 weeks; dexamethasone was administered at a dose of 40 mg orally on days 1 to 4, 9 to 12, and 17 to 20. Cycles were repeated every 4 weeks. Patients in arm B received dexamethasone alone at the same schedule as in arm A. Results: Two hundred seven patients were enrolled: 103 were randomly assigned to thalidomide plus dexamethasone and 104 were randomly assigned to dexamethasone alone; eight patients were ineligible. The response rate with thalidomide plus dexamethasone was significantly higher than with dexamethasone alone (63% v 41%, respectively; P = .0017). The response rate allowing for use of serum monoclonal protein levels when a measurable urine monoclonal protein was unavailable at follow-up was 72% v 50%, respectively. The incidence rates of grade 3 or higher deep vein thrombosis (DVT), rash, bradycardia, neuropathy, and any grade 4 to 5 toxicity in the first 4 months were significantly higher with thalidomide plus dexamethasone compared with dexamethasone alone (45% v 21%, respectively; P < .001). DVT was more frequent in arm A than in arm B (17% v 3%); grade 3 or higher peripheral neuropathy was also more frequent (7% v 4%, respectively). Conclusion: Thalidomide plus dexamethasone demonstrates significantly superior response rates in newly diagnosed myeloma compared with dexamethasone alone. However, this must be balanced against the greater toxicity seen with the combination.
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Clinical testing revealed the efficacy and tolerability of thalidomide in patients with multiple myeloma.
“Clinical testing revealed the efficacy and tolerability of thalidomide in patients with multiple myeloma (MM)8–10”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [10]
Thalidomide itself rarely causes thrombocytopenia.
“Thalidomide itself is an exception, given that it rarely causes thrombocytopenia10”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [10]
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- Authors
- Rajkumar, S. V., Blood, E., Vesole, D., Fonseca, R., & Greipp, P. R.
- Affiliations
- Mayo Clinic (US)
- From the Division of Hematology, Mayo Clinic, Rochester, MN; Eastern Cooperative Oncology Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA; the Medical College of Wisconsin, Milwaukee, WI; and Mayo Clinic, Scottsdale, AZ
- Venue
- Journal of Clinical Oncology
- Published
- 2006-01-20
- Volume
- 24
- Issue
- 3
- Pages
- 431-436
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2148188974
- Cited by
- 865
- References
- 28
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 10 · 2023: 10 · 2022: 16 · 2021: 21 · 2020: 16 · 2019: 12 · 2018: 17 · 2017: 26 · 2016: 33 · 2015: 32 · 2014: 38 · 2013: 51 · 2012: 60
- FWCI
- 56.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (U10CA066636, CA-23318, CA13650, R01CA093842, CA66636, U10CA013650, CA 93842, U10CA023318, U10CA021115, CA 21115)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Keywords
- thalidomide, dexamethasone, multiple myeloma, induction therapy, newly diagnosed multiple myeloma, combination chemotherapy, response rate, deep vein thrombosis, peripheral neuropathy, drug toxicity
- MeSH terms
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Synergism, Female, Humans, Male, Middle Aged, Multiple Myeloma, Thalidomide, Survival Analysis, Treatment Outcome, Disease-Free Survival
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