Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: Effects of prophylactic and therapeutic anticoagulation

Maurizio Zangari, Bart Barlogie, Elias Anaissie, Fariba Saghafifar, Paul Eddlemon, Joth Jacobson, Choon Kee Lee, Raymond Thertulien, Giampaolo Talamo, Teri Thomas, Frits Van Rhee, Athanasios Fassas, Louis Fink, Guido Tricot

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Abstract

A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86%) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4.5; P < 0.0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11%). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4%. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention.

Original languageEnglish (US)
Pages (from-to)715-721
Number of pages7
JournalBritish Journal of Haematology
Volume126
Issue number5
DOIs
StatePublished - Sep 1 2004

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Thalidomide
Therapeutic Uses
Multiple Myeloma
Venous Thrombosis
Drug Therapy
Low Molecular Weight Heparin
Warfarin
Arm
Consolidation Chemotherapy
Enoxaparin
Induction Chemotherapy
Incidence
Thrombosis
Transplantation
Transplants

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Zangari, Maurizio ; Barlogie, Bart ; Anaissie, Elias ; Saghafifar, Fariba ; Eddlemon, Paul ; Jacobson, Joth ; Lee, Choon Kee ; Thertulien, Raymond ; Talamo, Giampaolo ; Thomas, Teri ; Van Rhee, Frits ; Fassas, Athanasios ; Fink, Louis ; Tricot, Guido. / Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy : Effects of prophylactic and therapeutic anticoagulation. In: British Journal of Haematology. 2004 ; Vol. 126, No. 5. pp. 715-721.
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title = "Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: Effects of prophylactic and therapeutic anticoagulation",
abstract = "A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86{\%}) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4.5; P < 0.0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11{\%}). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4{\%}. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention.",
author = "Maurizio Zangari and Bart Barlogie and Elias Anaissie and Fariba Saghafifar and Paul Eddlemon and Joth Jacobson and Lee, {Choon Kee} and Raymond Thertulien and Giampaolo Talamo and Teri Thomas and {Van Rhee}, Frits and Athanasios Fassas and Louis Fink and Guido Tricot",
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Zangari, M, Barlogie, B, Anaissie, E, Saghafifar, F, Eddlemon, P, Jacobson, J, Lee, CK, Thertulien, R, Talamo, G, Thomas, T, Van Rhee, F, Fassas, A, Fink, L & Tricot, G 2004, 'Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: Effects of prophylactic and therapeutic anticoagulation', British Journal of Haematology, vol. 126, no. 5, pp. 715-721. https://doi.org/10.1111/j.1365-2141.2004.05078.x

Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy : Effects of prophylactic and therapeutic anticoagulation. / Zangari, Maurizio; Barlogie, Bart; Anaissie, Elias; Saghafifar, Fariba; Eddlemon, Paul; Jacobson, Joth; Lee, Choon Kee; Thertulien, Raymond; Talamo, Giampaolo; Thomas, Teri; Van Rhee, Frits; Fassas, Athanasios; Fink, Louis; Tricot, Guido.

In: British Journal of Haematology, Vol. 126, No. 5, 01.09.2004, p. 715-721.

Research output: Contribution to journalArticle

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T1 - Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy

T2 - Effects of prophylactic and therapeutic anticoagulation

AU - Zangari, Maurizio

AU - Barlogie, Bart

AU - Anaissie, Elias

AU - Saghafifar, Fariba

AU - Eddlemon, Paul

AU - Jacobson, Joth

AU - Lee, Choon Kee

AU - Thertulien, Raymond

AU - Talamo, Giampaolo

AU - Thomas, Teri

AU - Van Rhee, Frits

AU - Fassas, Athanasios

AU - Fink, Louis

AU - Tricot, Guido

PY - 2004/9/1

Y1 - 2004/9/1

N2 - A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86%) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4.5; P < 0.0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11%). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4%. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention.

AB - A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86%) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4.5; P < 0.0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11%). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4%. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention.

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