Abstract
Abstract 1090
The incidence of venous thromboembolism (VTE) in patients with multiple myeloma (MM) is high in patients treated with thalidomide (T)- and lenalidomide (L)-based regimens containing dexamethasone (D) and/or cytotoxic chemotherapy (C). Consensus guidelines recommend routine thromboprophylaxis but reliable data from randomized controlled trials are lacking. Recent observational studies have suggested that thromboprophylaxis might be efficacious in decreasing the risk of VTE in this population.
To determine the absolute rates of VTE with and without different thromboprophylactic agents (ASA, warfarin, low-molecular-weight-heparin [LMWH]) in patients with newly diagnosed or previously treated MM receiving T- or L-based regimens.
A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews of published studies up to Jan 2010.
A total of 66 studies were included in the analyses. Of these, 61 (4264 patients) and 5 (1119 patients) assessed T- and L-based regimens, respectively.
Thalidomide-based regimens
The rates of VTE (per 100 patient-cycles) in patients with newly diagnosed MM treated with T-based regimens:
| MM Treatment . | No prophylaxis . | Any prophylaxis . | ASA . | Warfarin 1-1.25 mg/d . | Prophylactic LMWH . | Therapeutic anticoagulation . |
|---|---|---|---|---|---|---|
| T alone (95% CI) | 1.3 | NA | NA | NA | 0.5 | NA |
| (0.4-2.7) | (0.4-0.6) | |||||
| (n=380) | (n=64) | |||||
| TD (95% CI) | 4.1 | 2.6 | 2.3 | 2.8 | 2.1 | 1.6 |
| (2.8-5.9) | (2.1-3.2) | (0.9-7.9) | (2.0-3.9) | (1.1-3.6) | (0.2-4.1) | |
| (n=628) | (n=993) | (n=80) | (n=387) | (n=446) | (n=80) |
| MM Treatment . | No prophylaxis . | Any prophylaxis . | ASA . | Warfarin 1-1.25 mg/d . | Prophylactic LMWH . | Therapeutic anticoagulation . |
|---|---|---|---|---|---|---|
| T alone (95% CI) | 1.3 | NA | NA | NA | 0.5 | NA |
| (0.4-2.7) | (0.4-0.6) | |||||
| (n=380) | (n=64) | |||||
| TD (95% CI) | 4.1 | 2.6 | 2.3 | 2.8 | 2.1 | 1.6 |
| (2.8-5.9) | (2.1-3.2) | (0.9-7.9) | (2.0-3.9) | (1.1-3.6) | (0.2-4.1) | |
| (n=628) | (n=993) | (n=80) | (n=387) | (n=446) | (n=80) |
The rates of VTE (per 100 patient-months) in patients with previously treated MM managed with T-based regimens:
| MM Treatment . | No prophylaxis . | ASA . | Warfarin 1-1.25 mg/d . | Prophylactic LMWH . | Therapeutic doses of anticoagulation . |
|---|---|---|---|---|---|
| T alone (95% CI) | 0.4 | NA | NA | 0 | NA |
| (0.2-0.8) | (0-1.72) | ||||
| (n=706) | (n=17) | ||||
| T+ prednisone (95% CI) | 0.6 | NA | NA | NA | NA |
| (0.2-1.1) | |||||
| (n=258) | |||||
| TC (95% CI) | 0.4 | 0.4 | NA | NA | |
| (0.01-1.2) | (0.01-0.9) | ||||
| (n=38) | (n=37) | ||||
| TD (95% CI) | 0.8 | NA | NA | NA | NA |
| (0.1-2.1) | |||||
| (n=321) | |||||
| TDC agents (95% CI) | 0.9 | NA | 2.4 | NA | 0 |
| (0.3-1.8) | (1.3-4.0) | (0-2.2) | |||
| (n=321) | (n=102) | (n=18) | |||
| TDC including doxorubicin (95% CI) | 6.7 | NA | 3.5 | NA | |
| (0.5-18.9) | (1.2-6.5) | ||||
| (n=331) | (n=50) |
| MM Treatment . | No prophylaxis . | ASA . | Warfarin 1-1.25 mg/d . | Prophylactic LMWH . | Therapeutic doses of anticoagulation . |
|---|---|---|---|---|---|
| T alone (95% CI) | 0.4 | NA | NA | 0 | NA |
| (0.2-0.8) | (0-1.72) | ||||
| (n=706) | (n=17) | ||||
| T+ prednisone (95% CI) | 0.6 | NA | NA | NA | NA |
| (0.2-1.1) | |||||
| (n=258) | |||||
| TC (95% CI) | 0.4 | 0.4 | NA | NA | |
| (0.01-1.2) | (0.01-0.9) | ||||
| (n=38) | (n=37) | ||||
| TD (95% CI) | 0.8 | NA | NA | NA | NA |
| (0.1-2.1) | |||||
| (n=321) | |||||
| TDC agents (95% CI) | 0.9 | NA | 2.4 | NA | 0 |
| (0.3-1.8) | (1.3-4.0) | (0-2.2) | |||
| (n=321) | (n=102) | (n=18) | |||
| TDC including doxorubicin (95% CI) | 6.7 | NA | 3.5 | NA | |
| (0.5-18.9) | (1.2-6.5) | ||||
| (n=331) | (n=50) |
Lenalidomide-based regimens
The rates of VTE (per 100 patient-cycles) in patients with newly diagnosed MM treated with L-based regimens:
| MM Treatment . | No prophylaxis . | Any prophylaxis . | ASA . |
|---|---|---|---|
| LD (95% CI) | 0.8 | 0.7 | 0.9 |
| (0.07-2.0) | (0.5-1.1) | (0.5-1.5) | |
| (n=278) | (n=349) | (n=172) |
| MM Treatment . | No prophylaxis . | Any prophylaxis . | ASA . |
|---|---|---|---|
| LD (95% CI) | 0.8 | 0.7 | 0.9 |
| (0.07-2.0) | (0.5-1.1) | (0.5-1.5) | |
| (n=278) | (n=349) | (n=172) |
The rate VTE (per 100 patient-months) in patients with previously treated MM managed with L-based regimens:
| MM Treatment . | No prophylaxis . | ASA . |
|---|---|---|
| LD (95% CI) | 0.7 (0.4–0.9)(n=361) | NA |
| LDC including doxorubicin (95% CI) | NA | 0.6 (0.01–2.1)(n=131) |
| MM Treatment . | No prophylaxis . | ASA . |
|---|---|---|
| LD (95% CI) | 0.7 (0.4–0.9)(n=361) | NA |
| LDC including doxorubicin (95% CI) | NA | 0.6 (0.01–2.1)(n=131) |
None of the studies reported major bleeding events.
The definition for VTE varied across studies. Most studies did not outline the diagnostic criteria for VTE. Data are not available (NA) for all prophylaxis regimens.
Patients with newly diagnosed or previously treated MM receiving T- or L-based regimens are at high risk of VTE. It is uncertain whether thromboprophylaxis provides a clear benefit, especially in those receiving L-based therapy or have previously treated disease. Randomized controlled trials are needed to address this important clinical need.
Lee:Eisai: Research Funding; Sanofi Aventis: Consultancy, Honoraria; Leo Pharma: Consultancy; Pfizer: Consultancy, Honoraria; Bayer: Honoraria; Boehringer Ingelheim: Consultancy, Honoraria, Speakers Bureau.
Author notes
Asterisk with author names denotes non-ASH members.
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