Tandem autologous stem cell transplantation in high-risk patients with newly diagnosed multiple myeloma: Feasibility and preliminary results.

2019 ◽  
Vol 19 (10) ◽  
pp. e203-e204
Author(s):  
Javier De La Rubia ◽  
María Jiménez ◽  
Mario A. Legarda Campo ◽  
Lucía Rubio ◽  
Eva Francés ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Newly Diagnosed ◽  
Preliminary Results ◽  
High Risk Patients ◽  
Risk Patients

scholarly journals RVD induction and autologous stem cell transplantation followed by lenalidomide maintenance in newly diagnosed multiple myeloma: a phase 2 study of the Finnish Myeloma Group

2019 ◽  
Vol 98 (12) ◽  
pp. 2781-2792 ◽  
Author(s):  
Sini Luoma ◽  
Pekka Anttila ◽  
Marjaana Säily ◽  
Tuija Lundan ◽  
Jouni Heiskanen ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Maintenance Phase ◽  
Molecular Response ◽  
Newly Diagnosed ◽  
High Risk Patients ◽  
Risk Patients

Abstract Autologous stem cell transplantation (ASCT) combined with novel agents is the standard treatment for transplant-eligible, newly diagnosed myeloma (NDMM) patients. Lenalidomide is approved for maintenance after ASCT until progression, although the optimal duration of maintenance is unknown. In this trial, 80 patients with NDMM received three cycles of lenalidomide, bortezomib, and dexamethasone followed by ASCT and lenalidomide maintenance until progression or toxicity. The primary endpoint was the proportion of flow-negative patients. Molecular response was assessed if patients were flow-negative or in stringent complete response (sCR). By intention to treat, the overall response rate was 89%. Neither median progression-free survival nor overall survival (OS) has been reached. The OS at 3 years was 83%. Flow-negativity was reached in 53% and PCR-negativity in 28% of the patients. With a median follow-up of 27 months, 29 (36%) patients are still on lenalidomide and 66% of them have sustained flow-negativity. Lenalidomide maintenance phase was reached in 8/16 high-risk patients but seven of them have progressed after a median of only 6 months. In low- or standard-risk patients, the outcome was promising, but high-risk patients need more effective treatment approach. Flow-negativity with the conventional flow was an independent predictor for longer PFS.

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.

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