scholarly journals Cost-Effectiveness of Induction Treatment with Bortezomib Added to Thalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation in Germany

2013 ◽  
Vol 16 (7) ◽  
pp. A409-A410
Author(s):  
C. van Beurden-Tan ◽  
L. Rosiñol ◽  
J. Diels ◽  
D. Wirth ◽  
O. Chirita ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Cost Effectiveness ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Induction Treatment ◽  
Newly Diagnosed

Bortezomib (VELCADE®) Plus Dexamethasone as Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma: Preliminary Results of an IFM Phase II Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1490-1490 ◽  
Author(s):  
Jean-Luc Harousseau ◽  
Michel Attal ◽  
Xavier Leleu ◽  
Remy Gressin ◽  
Cyrille Hulin ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Partial Remission ◽  
Induction Treatment ◽  
Newly Diagnosed ◽  
Preliminary Results ◽  
Grade 3

Abstract When patients (pts) with newly diagnosed multiple myeloma (MM) are treated with autologous stem cell transplantation (ASCT), the standard induction therapy is a dexamethasone (Dex) based regimen. Currently, the use of VAD or Dex alone results in a complete remission (CR) rate of <10%. In an ongoing ECOG trial comparing Dex alone to the combination thalidomide plus Dex, preliminary results did not show a clear advantage of the combination (Rajkumar ASCO 2004). Since achievement of CR is a major objective in the treatment of MM, better therapeutic regimens are being investigated. Bortezomib is currently approved in the US and in the EU for the treatment of relapsed/refractory MM. Both in vitro studies and preliminary clinical experience in relapsed/refractory pts have suggested that the combination of bortezomib and Dex could further improve the results achieved with bortezomib alone. The IFM group initiated a Phase II open trial assessing the combination of bortezomib and Dex in pts with previously untreated MM and who are candidates for ASCT. The regimen consisted of bortezomib 1.3mg/m² iv on days 1, 4, 8, 11 and Dex 40 mg per os days 1–4, 9–12 (for the first 2 cycles, days 1–4 only for the last 2 cycles), administered on 4 consecutive 21 days cycles. Stem cell collection was performed just before cycle 4 after G-CSF priming. The primary objective of the study was CR rate after 4 cycles. As of August 1, 47 pts have been recruited and data is available for the first 18 pts. The median age is 53 years (38–63) Sixteen / 18 pts received 4 cycles: 1 patient progressed after 3 cycles and in one case the last two injections of bortezomib were not performed because of grade 3 neuropathy. The overall results were as follows: CR (negative electrophoresis) 3; very good partial remission (90% reduction of M component) 2; partial remission (50% reduction of the serum M component or 90% reduction of the urine M component) 10; failure (stable disease or progression ) 3. The overall response rate was 83% and the CR rate was 17%. Side effect were usually mild (grade 1/2); only one grade 3 neuropathy was recorded. In all cases stem cells could be adequately collected. These preliminary results appear to be very encouraging and the bortezomib / Dex combination appears effective and well tolerated in pts with newly diagnosed MM. The results will be updated at time of presentation. If updated analysis confirms currently available data, the IFM will start a large randomized phase III trial comparing VAD and bortezomib / Dex as induction treatment prior to ASCT in pts with newly diagnosed MM up to the age of 65.

Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study

2007 ◽  
Vol 25 (17) ◽  
pp. 2434-2441 ◽  
Author(s):  
Michele Cavo ◽  
Patrizia Tosi ◽  
Elena Zamagni ◽  
Claudia Cellini ◽  
Paola Tacchetti ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Newly Diagnosed ◽  
Free Survival ◽  
To Receive

Purpose We performed a prospective, randomized study of single (arm A) versus double (arm B) autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM). Patients and Methods A total of 321 patients were enrolled onto the study and were randomly assigned to receive either a single course of high-dose melphalan at 200 mg/m2 (arm A) or melphalan at 200 mg/m2 followed, after 3 to 6 months, by melphalan at 120 mg/m2 and busulfan at 12 mg/kilogram (arm B). Results As compared with assignment to the single-transplantation group (n = 163 patients), random assignment to receive double ASCT (n = 158 patients) significantly increased the probability to attain at least a near complete response (nCR; 33% v 47%, respectively; P = .008), prolonged relapse-free survival (RFS) duration of 18 months (median, 24 v 42 months, respectively; P < .001), and significantly extended event-free survival (EFS; median, 23 v 35 months, respectively; P = .001). Administration of a second transplantation and of novel agents for treating sequential relapses in up to 50% of patients randomly assigned to receive a single ASCT likely contributed to prolong the survival duration of the whole group, whose 7-year rate (46%) was similar to that of the double-transplantation group (43%; P = .90). Transplantation-related mortality was 3% in arm A and 4% in arm B (P = .70). Conclusion In comparison with a single ASCT as up-front therapy for newly diagnosed MM, double ASCT effected superior CR or nCR rate, RFS, and EFS, but failed to significantly prolong overall survival. Benefits offered by double ASCT were particularly evident among patients who failed at least nCR after one autotransplantation.

Up-Front Therapy for Multiple Myeloma: A Survey of Practice Patterns in the USA.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5172-5172
Author(s):  
Kavita Natarajan ◽  
Gary H. Lyman ◽  
Oscar F. Ballester
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Initial Therapy ◽  
Newly Diagnosed ◽  
The Usa ◽  
Choice Of Therapy

Abstract Introduction: Several treatment programs are available for the initial management of patients with multiple myeloma, with no clear documented advantage(s) of one regimen over the others in terms of time to progression (TTP) or overall survival (OS). Materials and Methods: A questionnaire was mailed to 540 randomly selected members of ASH during early 2005. Practitioners were asked their choice of therapy for newly diagnosed myeloma patients during 2004, based on 2005 NCCN guidelines, including: 1) melphalan/prednisone (MP), 2) vincristine / adriamycin / decadron (VAD), 3) high-dose decadron (HD), 4) thalidomide / decadron (Thal/Dex), 5) doxyl / vincristine / decadron (DVD); the options of a clinical trial (CT) or “other” were also included. Physicians were asked about factors influencing their choice of therapy for individual patients and their recommendations for autologous stem cell transplantation as part of the initial treatment schema. Results: Surveys were returned by 123 physicians(19.2%), of which 93 contained evaluable data. Among responders, 52% were in private practice and 47% in academic institutions and 74% respondants reporting having been in practice for more than 10 years. A large majority of physicians (74%) utilized 3 or more different regimens, only 10.7% of responders used a single regimen for all of their patients. Thal/Dex was used by 87% of responders, with 47% of them recommending this regimen in ≥ 50% of their patients. MP, HD and VAD were used by 67.7%, 49% and 44% of responders, but only 10.7%, 4% and 3% respectively, recommended them to ≥ 50% of their patients. DVD was used by 25% of physicians. Of respondants, 64.5% did not accrued patients to clinical trials and only 7.5% of physicians accrued ≥ 50% of their patients to clinical trials. No significant differences in the choice of regimen were apparent based on years of practice. Physicians in academic centers tended to use HD (p =.002) and accrue patients to CT (p=. 001) more often than those in private practice. Factors identified as important in selecting initial therapy for individual patients included: age (92%); performance status (95%); prognostic factors, such as β2-microglobulin and cytogenetics (75%); and candidacy for stem cell transplantation (93%). Respondants consider autologous stem cell transplantation as part of the initial therapy for all eligible patients (47%), only those with responsive disease (42%) and normal renal function (30%); only in selected cases (76%). Conclusions: Thal/Dex appears to be currently the most commonly recommended up-front therapy for multiple myeloma in the USA, in spite of the lack of published data documenting patient benefit in terms of TTP and OS. A sizable proportion of physicians do not recommend autologous stem cell transplantation as part of the initial therapy of newly diagnosed myeloma patients despite confirmed randomized clinical trials documenting benefit.

Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (VELCADE®, Thalidomide, Dexamethasone) Induction Followed by High-Dose Therapy with Autologous Stem Cell Transplantation and Maintenance Treatment with VELCADE for Newly Diagnosed Multiple Myeloma: Interim Results of Phase II Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 952-952 ◽  
Author(s):  
Sung-Soo Yoon ◽  
Hye Jin Kim ◽  
Dong Soon Lee ◽  
Hyeon Seok Eom ◽  
Jun Ho Jang ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Maintenance Treatment ◽  
Response Rate ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Newly Diagnosed

Abstract Introduction Effective reduction of myeloma before autologous stem cell transplantation (ASCT) prolongs survival in multiple myeloma patients. Recently, incorporation of novel agents resulted in improved response rate and reduced side effect in newly diagnosed multiple myeloma. Method: Patients are planned to receive 2 cycles of VAD (vincristine 0.4mg D1-4, adriamycin 9mg/m2 D1-4, dexamethasone 40mg D1-4, 9–12 every 3 weeks), and VTD (bortezomib 1.3mg/m2 D1, 4, 8, 11, thalidomide 100mg daily, dexamethasone 40mg D1-4, 9–12 every 3 weeks). High dose melphalan (200mg/m2) is used as a conditioning regimen for ASCT. Bortezomib (1.3mg/m2) as a maintenance treatment is administered weekly x 4 times every 6 weeks for 4 cycles after ASCT. Response was assessed by EBMT criteria, with additional category of nCR. Adverse events were graded by the NCI-CTCAE, Version 3.0. Result: At this interim analysis, 60 patients have been entered into the ongoing trial, and efficacy could be assessed in 53 patients. After 2 cycles of VAD, response rate was 70%. After VTD, two patients showed further improvement with additional CR, and an overall response was 97% with 14% CR. Especially, patients with poor prognostic cytogenetics (n=6) all responded after VTD. So far, autologous stem cells were successfully collected in all 28 patients with a median CD34+ count of 7.8 x 106/kg (range, 2.17–44.7 x 106/kg). In 24 patients who underwent autologous stem cell transplantation, five patients gained additional CR. There was no progression in patients completed bortezomib maintenance (n=9, CR 77%). The median follow-up duration was 6 months, median time to response was 1.4 months, and median overall survival was not reached. Grade 3,4 hematologic toxicity was more frequently observed after VAD than VTD (anemia 15.8%, 4.6%, neutropenia 7.9%, 3.5%), and incidence of grade 2,3 peripheral neuropathy was low (VAD 3.5%, VTD 7%). Conclusion: Sequential VAD and VTD induction therapy in newly diagnosed multiple myeloma was highly effective, even in patients with poor prognostic cytogenetics, and did not prejudice stem cell collection. VTD could have contributed to increased RR and minimized side effects. An updated results will be presented at the ASH meeting. *Protocol Number: KMM51-NCT00378755.

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