Background: Venous thromboembolism (VTE) is a well known cancer complication generally associated with poor survival. We have analyzed the prognostic impact of the development of a thrombotic episode in newly diagnosed multiple myeloma (MM).

Methods: Newly diagnosed patients with symptomatic MM were eligible for enrollment. At registration, patients were randomly assigned to Thalidomide (Thal) or not; both arms received otherwise identical chemotherapy. A total of 668 patients entered the study. The two study arms were well balanced, in terms of age, Ig Subtype, cytogenetic, B2 microglobulin vs CRP. Baseline patients and disease characteristics were well balanced between those individuals who experienced VTE and the others. VTE patients were treated with LMWH followed by coumadin for at least 6 months. A 12 month landmark for VTE was used; group comparisons were performed for EFS and OS using the log rank test.

Results: With a median follow up of 53 months a total of 155 (23%) patients experienced VTE during treatment, 98 (30%) patients in the Thal arm and 57 (16%) in the non Thal arm. The development of thrombotic episode was not a negative factor for EFS (p=.1) or OS (p=0.1) (Figure 1) for the entire group as well as for the Thal/chemotherapy treated group (EF p=0.7, OS p=0.6). Patients who received only chemotherapy and developed a thrombotic episode experienced a significantly longer EFS (p=0.02) (Figure 2), and a similar trend in OS.

Conclusions: OS and EFS survival of myeloma patients treated with chemotherapy ± thalidomide is not affected by VTE development. Patients treated with chemotherapy (but not Thalidomide) who developed thrombosis during treatment experienced significantly longer EFS. Our observation supports a survival benefit associated with anticoagulation therapy in multiple myeloma patients.

Figure 1:

OS from 12 months post VAD by VTE

Figure 1:

OS from 12 months post VAD by VTE

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Figure 2:

EFS from 12 months post VAD by VTE in the Non Thalidomide arm

Figure 2:

EFS from 12 months post VAD by VTE in the Non Thalidomide arm

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Disclosures: Thalidomide use in newly diagnosed myeloma.; Millennium Phamaceuticals, Inc.; Celgene.; Speakers Bureau - Millennium Pharmaceuticals, Inc., Johnson & Johnson.

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