Considerations for Autologous Stem Cell Transplantation (ASCT) in Multiple Myeloma Patients

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1 Hello, my name is Suzanne Lentzsch. I am an associate professor of medicine at Columbia University Medical Center in New York. I am the clinical director of the Multiple Myeloma Amyloidosis Service. Today, I would like to share some considerations for autologous stem cell transplantation in patients with multiple myeloma. 1

2 Dr. Attal from France and Dr. Child from UK published in 1996 and 2003 two landmark studies in which they showed that patients receiving autologous cell transplantation have a better overall survival in comparison to patients receiving conventional dose or a standard therapy. 2

3 This was confirmed by other researchers such as Dr. Palumbo from Italy and Dr. Bladé from Spain. The outcome showed that the trials with the high-dose chemotherapy could increase the complete remission rate, the event-free survival, and also the overall survival rate. 3

4 Some considerations for autologous stem cell transplantation, usually a standard conditioning regimen is melphalan 200 mg/m 2 ; but in more frail patients, we can also give 140 mg/m 2, patients who have a sufficient performance score, adequate liver and pulmonary as well as cardiac function; I told you already that in patients receiving autologous high-dose chemotherapy, the PR and the complete remission rates are higher than in conventional chemotherapy. Also, we observe that overall survival and event-free survival is higher in high-dose chemotherapy with transplant than in conventional chemotherapy. Advanced age and impaired renal function are themselves not contraindications, but usually patients are below 75 years if they are considered eligible for transplantation. 4

5 Costa and his colleagues performed a very nice data analysis of the utilization of autologous stem cell transplantation in the US between 1995 and They estimated that around 240,000 new myeloma cases are diagnosed in this frame. We estimated that around 32,000 patients receive an autologous stem cell transplantation. Most of the patients, 68.3%, receive the autologous stem cell transplantation within less than a year from the diagnosis. That means that around 13.4 of the new cases of multiple myeloma receive an autologous stem cell transplantation. 5

6 They also performed a very nice analysis of the utilization of autologous stem cell transplant in patients over 65 years, patients between and 50 and 64 years, and less than 50 years, and you can nicely see on the slide that there is an increase in the stem cell transplant over the years and decades; and that in patients who are older than 65 years, only a minority, less than 10% of the patients received a transplant. In patients between 50 and 64 years, this percentage of autologous stem cell transplant increases up to almost 50%; and younger patients, younger than 50 years, almost over 50% received autologous stem cell transplant. 6

7 In this slide, you can see the NCCN Guideline brochure from The NCCN Guidelines designs three practice choices given a response after primary therapy. The high-dose therapy with autologous stem cell support is category I recommendation; that means it is the strongest by strength of evidence and uniformity of consensus. The patients can also refer within a clinical trial to an allogenic stem cell transplant, but this should only be considered for selected patient populations. The patients who respond very well to the initial response and do not belong to any high-risk category group can also continue the therapy until this response, but it is important that you always discuss the risks and benefits of the high-dose chemotherapy with autologous stem cell transplant in the eligible patients in order to make sure that patients can have a stem cell mobilization later and do not receive an alkylating agent like melphalan during the induction therapy. 7

8 The Mayo Clinic published certification from myeloma from a risk-adapted therapy in which they included nicely the role of autologous stem cell transplant. Standard-risk patients characterized by translocation 11;14, 6;14 or hyperdiploidy can start with four cycles lenalidomide, dexamethasone, or CyBorD, followed by an autologous stem cell transplantation. In case they have a nice response, we can also collect stem cells and continue with therapies, for instance like lenalidomide and dexamethasone. Transplant ineligible patients receive lenalidomide-dexamethasone or melphalanprednisone-thalidomide and can be later re-observed. Patients with intermediate-risk with a translocation 4;14 and cytogenic deletion of the chromosome 13 or hypodiploidy or plasma cell labeling index more than 3% should receive four cycles of bortezomib containing regimen, for instance CyBorD, and followed by an autologous stem cell transplant. Those patients should also continue with bortezomib-based therapy for a minimum of one year. Transplant ineligible patients can proceed or can receive melphalan-prednisone, and bortezomib-based regimen or also CyBorD. Highrisk patients defined by a deletion of the chromosome 17p, a translocation 14;16 or translocation 14;20 as well as gene expression profiling high-risk signature should receive four cycles of bortezomib-lenalidomide and dexamethasone followed by autologous stem cell transplantation and receive further, at least one year, of the VRD, bortezomib, lenalidomide, and dexamethasone. Transplant ineligible patients belong to the high-risk group and should receive bortezomib, lenalidomide, and dexamethasone. 8

9 The group of Costa, et al., also published very nicely the overall survival after autologous stem cell transplantation certified by the period of the transplant, and you can nicely see that with the introduction of the new drug such as bortezomib and lenalidomide, the overall survival increased. Patients treated with high-dose chemotherapy and autologous stem cell transplant between 1995 and 1999 had a lower overall survival as patients treated between the timeframe of 2000 and 2004 in which bortezomib was already available, and had a lower overall survival of patients who had access to lenalidomide and who were treated between 2005 and 2010, but there are still open questions. 9

10 The questions are what is the efficacy of the high-dose chemotherapy in comparison with novel drugs? And further should we give single or tandem transplant? What is the role of allogeneic and mini-allogenic transplantation? Do all patients need a maintenance post stem cell therapy? And what is the best timing? Should the patients receive a high-dose chemotherapy with stem cell transplant early in the treatment or can it be delayed until they have the first relapse? 10

11 So, in order to address those questions, I would like to share with you some insights what is the role of transplantation in multiple myeloma in the era of novel drugs, and again could the stem cell transplant be delayed or given for relapse? 11

12 So in order to address this question, Dunavin and colleagues performed the retrospective analysis of the outcome of multiple myeloma patients receiving novel agent-based induction regimens, and you can see very nicely that there was no difference in the overall survival of those patients. There was a slight difference in the progression-free survival of patients between early and late transplantation, but this difference was not significant. So, this suggests that there is no difference in the early versus delayed autologous stem cell transplantation in patients who experience a relapse. 12

13 Dr. Kumar from the Mayo Clinic performed another retrospective analysis. He included in his analysis 290 patients. Those patients received as an induction therapy thalidomide-dexamethasone or lenalidomide-dexamethasone. He defined early stem cell transplantation for patients who received stem cell transplant within two months after stem cell harvest and 12 months within the diagnosis. Delayed autologous stem cell transplantation was defined by more than 12 months after the diagnosis. In his study, he found that the four-year overall survival was 73% in both groups with no significant difference. The time to progression in patients who received an early transplant was 20 months and patients who received the delayed transplant was 16 months. Again, there was no significant difference. 13

14 But nevertheless, those two trials are retrospective trials and the role of delayed autologous stem cell transplant in multiple myeloma can only be answered in prospective randomized clinical trials. 14

15 One of those randomized prospective trials is a trial by Dr. Palumbo from Italy. In his phase III trial, he compared melphalan, prednisone, lenalidomide, versus tandem autologous stem cell transplantation. The patient received lenalidomide 25 mg for 21 days and low-dose dexamethasone 40 mg weekly for four cycles. After the randomization, patients either receive melphalan, prednisone, and lenalidomide for six cycles or tandem transplantation with melphalan 200 mg. This was followed by another randomization. There is no maintenance, and maintenance with lenalidomide 10 mg until relapse. 15

16 In this trial, you can nicely see that there was an advantage for the autologous stem cell transplantation group. Patients receiving melphalan tandem transplant had a significantly increased two-year progression-free survival; but at the same time, those patients had significantly higher grade 3-4 neutropenia, also grade 3-4 infections and GI toxicity. 16

17 Another median follow-up analysis performed after 45 months from the diagnosis showed again that melphalan 200 significantly prolonged the progression-free survival compared to melphalan, prednisone, and lenalidomide. Lenalidomide maintenance significantly reduced the risk of progression independently from the previous treatment. The overall survival was similar between melphalan, prednisone, and lenalidomide and melphalan 200 mg. There was a trend for improved overall survival in patients receiving lenalidomide maintenance. 17

18 Another prospective randomized trial evaluating the rule of early versus delayed stem cell transplant is a trial of the IMF in France and the Dana-Farber Cancer Institute in United States. At this trial, newly diagnosed multiple myeloma patients are randomized and received in both arms three cycles of lenalidomide, bortezomib, and dexamethasone. This was followed in both arms by stem cell mobilization. The transplant arm received melphalan 200 mg and the non-transplant arm received lenalidomide, bortezomib, and dexamethasone for five cycles. Both cycles received maintenance and the patients without transplant can have a transplant at clinical relapse. This trial is ongoing 18

19 Another clinical trial, prospective randomized trial, evaluating the role of the stem cell transplant is a trial of Columbia University. In this trial, the patient received an upfront randomization either to a transplant or the non-transplant arm. In the transplant arm, patients received lenalidomide and dexamethasone for four cycles, followed by stem cell collection, autologous stem cell transplantation, and maintenance with lenalidomide for at most two years. The non-transplant arm, lenalidomide and dexamethasone is given for four cycles, followed by a stem cell collection, followed by four cycles of lenalidomide, dexamethasone and maintenance for two years. Patients on the non-transplant arm can receive an autologous stem cell transplant in case of relapse. 19

20 And last, another clinical trial evaluating the role of delayed versus early transplant is an initiative of the European Intergroup Trial. In this trial, the patient received three cycles of cyclophosphamide, bortezomib, and dexamethasone plus a stem cell apheresis. In the first randomization, they are randomized to bortezomib, melphalan, and prednisone versus high-dose therapy. The second randomization randomizes consolidation, non-consolidation versus lenalidomide, bortezomib, and dexamethasone, followed by lenalidomide maintenance therapy. Patients in the non-transplant arm again can receive a stem cell transplant at the time of relapse. 20

21 So in summary, autologous stem cell transplantation shows a superior event-free survival and overall survival when compared with combination and conventional chemotherapy. We did not see an increase in the overall survival in most of the trials using novel therapies. All patients should be evaluated at the diagnosis for transplant eligibility so that the risks and the benefits of the autologous hematopoietic stem cell transplantation can be reviewed in those patients. A delayed stem cell mobilization might fail after prolonged lenalidomide treatment, and that should be considered, and that is why most of the trials testing a delayed stem cell transplant include an early stem cell mobilization in their trials. A minority of patients will be eligible for an allogeneic stem cells transplant, but the value of the allogeneic stem cell transplantation should be remained investigational and only used within clinical trials. The role of the delayed autologous stem cell transplant should be evaluated in clinical trials until the final goal is defined. I would like to thank you for your attention listening to our brief consideration for the autologous stem cell transplantation. 21

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