Coagulation profiles and thromboembolic events of bortezomib plus thalidomide and dexamethasone therapy in newly diagnosed multiple myeloma

2011 ◽  
Vol 35 (2) ◽  
pp. 147-151 ◽  
Author(s):  
Yunfeng Shen ◽  
Xin Zhou ◽  
Zhi Wang ◽  
Guohua Yang ◽  
Yuanqiang Jiang ◽  
...  
2009 ◽  
Vol 9 (5) ◽  
pp. 394-398 ◽  
Author(s):  
Jian Li ◽  
Dao-Bin Zhou ◽  
Li Jiao ◽  
Ming Hui Duan ◽  
Wei Zhang ◽  
...  

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8096-8096 ◽  
Author(s):  
Geetika Srivastava ◽  
Vishal Rana ◽  
Martha Lacy ◽  
Morie A. Gertz ◽  
Angela Dispenzieri ◽  
...  

8096 Background: The combination of lenalidomide and dexamethasone (Len-Dex) is a commonly used initial therapy for newly diagnosed multiple myeloma. While the short-term outcomes with respect to response and toxicity is well-known, long-term outcome with this combination as initial therapy is not well described. Methods: We studied 286 consecutive patients with newly diagnosed MM seen at our institution, who received initial therapy with Len-Dex, and who had complete follow up records. Data regarding the clinical course was obtained from medical records. Results: The median (range) age at diagnosis was 63 (28-92) yrs; 166 (58% were ≤ 65 yrs and175 (61%) were male. The median estimated follow-up was 3.9 yrs (95% CI, 3.4, 4.2) and 203 (71%) pts were alive at the time of last follow up. The median estimated duration on Len-Dex was 5.3 mos (95% CI, 4.6, 6.4). The best overall response (≥PR) was 72%, including 26% with VGPR or better and 14 (5%) not being evaluable for a response. At last follow up, 41 (14%) patients were continuing on therapy. There were 93 pts (32%) who stayed on therapy for 12 months or more. Among these patients, the ORR was 86%, including 45% with VGPR or better. The median overall survival (OS) for the entire cohort from diagnosis was 7.4 yrs (95% CI; 5.8, NR) and the estimated 5-yr survival was 67%. There were 16 (5.5%) pts who died within a year of diagnosis. The median time to first disease progression, irrespective of transplant status, was 30.2 mos (95% CI, 25, 42). Overall, 143 (50%) of the patients have gone to stem cell transplant. Censoring those patients who proceeded to SCT prior to relapse at the time of BMT, the median TTP was 25.5 mos (95% CI, 22, 29). The median OS was 7.4 yrs for those ≤65 yrs, compared with 6.2 yrs for the older patients (P=0.01). The 5-yr OS estimate for patients in ISS stage 1, 2 and 3 were 82, 65, and 44 months respectively. Conclusions: The current study provides long-term estimates of responses and survival in a series of patients treated initially with lenalidomide and dexamethasone. The median survival of nearly 8 years reflects the efficacy of the novel agents both at diagnosis and at relapse and confirms the survival improvements seen in MM in the last decade.


Leukemia ◽  
2013 ◽  
Vol 27 (10) ◽  
pp. 2062-2066 ◽  
Author(s):  
G Srivastava ◽  
V Rana ◽  
M Q Lacy ◽  
F K Buadi ◽  
S R Hayman ◽  
...  

2010 ◽  
Vol 90 (2) ◽  
pp. 225-226 ◽  
Author(s):  
Chiharu I. Kobayashi ◽  
Go Yamamoto ◽  
Akimasa Hayashi ◽  
Satoshi Ota ◽  
Yoichi Imai ◽  
...  

Blood ◽  
2018 ◽  
Vol 132 (20) ◽  
pp. 2154-2165 ◽  
Author(s):  
Michael A. Chapman ◽  
Jonathan Sive ◽  
John Ambrose ◽  
Claire Roddie ◽  
Nicholas Counsell ◽  
...  

Abstract Improving outcomes in multiple myeloma will involve not only development of new therapies but also better use of existing treatments. We performed RNA sequencing on samples from newly diagnosed patients enrolled in the phase 2 PADIMAC (Bortezomib, Adriamycin, and Dexamethasone Therapy for Previously Untreated Patients with Multiple Myeloma: Impact of Minimal Residual Disease in Patients with Deferred ASCT) study. Using synthetic annealing and the large margin nearest neighbor algorithm, we developed and trained a 7-gene signature to predict treatment outcome. We tested the signature in independent cohorts treated with bortezomib- and lenalidomide-based therapies. The signature was capable of distinguishing which patients would respond better to which regimen. In the CoMMpass data set, patients who were treated correctly according to the signature had a better progression-free survival (median, 20.1 months vs not reached; hazard ratio [HR], 0.40; confidence interval [CI], 0.23-0.72; P = .0012) and overall survival (median, 30.7 months vs not reached; HR, 0.41; CI, 0.21-0.80; P = .0049) than those who were not. Indeed, the outcome for these correctly treated patients was noninferior to that for those treated with combined bortezomib, lenalidomide, and dexamethasone, arguably the standard of care in the United States but not widely available elsewhere. The small size of the signature will facilitate clinical translation, thus enabling more targeted drug regimens to be delivered in myeloma.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4206-4206
Author(s):  
Velu Nair ◽  
Satyaranjan Das ◽  
Sanjeevan Sharma ◽  
V. K. Jha ◽  
S. Bhattacharya ◽  
...  

Abstract Abstract 4206 Introduction Multiple myeloma is a plasma cell tumor which accounts for about 10% of hematological malignancies. In recent years some advances in the management of this malignancy have been achieved, especially the newer drugs like thalidomide, lenalidomide and bortezomib. Lenalidomde, a second generation immunomodulatory drug has been shown in various series to be a highly effective agent in management of newly diagnosed as well as relapsed cases of myeloma. The incidence of venous thromboembolism in patients of myeloma taking Lenalidomide – Dexamethasone therapy has been reported as high as 17 %. The risk of thromboembolism is to some extent determined by genetic predisposition of a population. There are no published reports from the Indian subcontinent addressing the incidence of venous thromboembolism in patients with newly diagnosed or relapsed multiple myeloma treated with Lenalidomide – Dexamethasone. Patients and Methods Forty one consecutive patients diagnosed at our centre with multiple myeloma either afresh (n=30) or relapsed on a previously different treatment regime (n=11), were studied between Oct2007 to Jul 2009. Diagnosis was based on serum electrophoresis and immunofixation, bone marrow plasmacytosis, and relevant tissue involvement. Patients were staged as per Durie Salmon system, and all our cases were found to be in stage 3 (3A = 34 cases, 3B = 7 cases). Detailed baseline clinical, haematological, and biochemical parameters were recorded. Colour Doppler flow imaging (CDFI) using a Philips 5000 imager of the lower limbs by an experienced radiologist was performed in all patients for DVT. D dimer using immunoturbidometric semi quantitative slide agglutination assay which measures fibrinogen equivalent units which is usually twice the actual D dimer value (<1.0 mcg/ml as normal cut off, 1.0 – 2.5 mcg/ml as indeterminate) was measured in all cases at diagnosis. All patients were started on therapy with Lenalidomide 25 mg a day for 21 consecutive days every month, with dose modification for renal insufficiency as per GFR. Dexamethasone 40 mg a day for first four days was given to all cases. Low dose aspirin 75 mg / d was used as thromboprophylaxis. Patients were followed up monthly with clinical, haematological and biochemical monitoring, specifically looking for any progression of myeloma parameters. Screening for occurrence of DVT was done using CDFI, D dimer, and thorough clinical examination at baseline and at one, three and six months interval from initiation of therapy. Results We report an overall response of 95% (nCR + CR : 30%) in newly diagnosed cases of multiple myeloma and 81.8% (nCR + CR : 36%) in patients with thalidomide failure / intolerant group. The primary toxic effect of lenalidomide was haematological and was manageable with dose adjustment of lenalidomide and supportive care. D dimer levels were found to be in the range of 0.5 to 2.4 mcg/ml (mean = 1.46 mcg/ml). On detailed follow up for upto six months there was no episode of venous thromboembolism recorded in any of the patients. All patients were asymptomatic for DVT and CDFI of lower limbs was normal at all points of examination in all patients of myeloma, newly diagnosed or relapsed. Conclusion Lenalidomide – Dexamethasone therapy is a highly effective regime for treatment of newly diagnosed and relapsed myeloma patients. In our cohort of both relapsed and fresh cases (n=41), on thromboprophylaxis with 75 mg asprin, not a single case of DVT was documented, proving its safety profile for venous thromboembolism. Larger trials would however be required to ascertain the exact risk of thromboembolism in patients of myeloma taking this treatment regime. Disclosures: No relevant conflicts of interest to declare.


2020 ◽  
Vol 99 (10) ◽  
pp. 2351-2356
Author(s):  
Yasushi Onishi ◽  
Hisayuki Yokoyama ◽  
Yuna Katsuoka ◽  
Toshihiro Ito ◽  
Tomohumi Kimura ◽  
...  

2014 ◽  
Vol 55 (12) ◽  
pp. 2842-2849 ◽  
Author(s):  
Tomer M. Mark ◽  
Isaac A. Bowman ◽  
Adriana C. Rossi ◽  
Manan Shah ◽  
Melissa Rodriguez ◽  
...  

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