TREATMENT FOR NON-TRANSPLANT ELIGIBLE MULTIPLE MYELOMA
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1 TREATMENT FOR NON-TRANSPLANT ELIGIBLE MULTIPLE MYELOMA Ekarat Rattarittamrong, MD Division of Hematology Department of Internal Medicine Faculty of Medicine Chiang Mai University
2 OUTLINE Overview of treatment for non-transplant eligible MM Current TMWG Guideline Update in non-transplant eligible MM induction treatment
3 OUTLINE Overview of treatment for non-transplant eligible MM Current TMWG Guideline Update in non-transplant eligible MM induction treatment
4 TREATMENT FOR NON-TRANSPLANT ELIGIBLE MM: OVERVIEW Multiple myeloma predominantly affects elderly patients The elderly multiple myeloma population is highly heterogeneous Biologic, genetic prognostic disease-related factors and age are insufficient to explain different disease and treatment outcome Zweegman S. Curr Opin Oncol 2017;29:
5 GERIATRIC ASSESSMENT PREDICTS SURVIVAL IN ELDERLY MM: IMWG OS 3-yr 84% 76% PFS 57% 3-yr 48% 41% 33% PFS OS Palumbo A. Blood 2015;125:
6 GERIATRIC ASSESSMENT Age, y < > 80 Score HR (95% CI) ( ) 2.40 ( ) Score 0: Fit 1: Intermediate fitness ADL < 4 > ( ) > 2: Frail IADL > 5 < 5 CCI < 1 > ( ) ( ) ADL: Activity of Daily Living IADL: Lawton Instrumental Activity of Daily Living CCI: Charlson Comorbidity Index Palumbo A. Blood 2015;125:
7 TREATMENT FOR NON-TRANSPLANT ELIGIBLE MM: OVERVIEW Consideration of treatment adjustment based on patient fitness IMWG, International Myeloma Working Group; R-MCI, Revised Myeloma Comorbidity Index Zweegman S. Curr Opin Oncol 2017;29:
8 Zweegman S. Curr Opin Oncol 2017;29:
9 TREATMENT FOR NON-TRANSPLANT ELIGIBLE MM: OVERVIEW Parameters to consider in decision-making process in frail patients with MM Patient characteristic Medical History Criteria to start treatment Disease characteristic Goal of treatment Age Functional and independence status (ADL and IADL) Comorbidity (CCI) Psychosocial status Cardiovascular disease Thromboembolism Diabetes Renal impairment Peripheral neuropathy Myeloma-defining events: CRAB or Biomarkers of malignancy Cytogenetics Stage (ISS) Tumor aggressiveness Response (CR) Disease control Quality of life ADL, Activity of Daily Living; CCI, Charlson comorbidity index; CR, complete response; IADL, Instrumental Activity of Daily Living; ISS, International Staging System; Larocca A. J Clin Oncol 2016;34:
10 TREATMENT FOR NON-TRANSPLANT ELIGIBLE MM: OVERVIEW Wildes TM. J Clin Oncol 2014;32:
11 OUTLINE Overview of treatment for non-transplant eligible MM Current TMWG Guideline Update in non-transplant eligible MM induction treatment
12 Newly diagnosed non-transplant candidate myeloma Induction therapy x 3-4 cycles Response > PR Stable/progressive disease Continue therapy to reach a treatment plateau (treatment should be continued for at least 2 cycles beyond best response) or as in the clinical trial Salvage therapy Follow up and monitor disease status q 3 mo Consider maintenance therapy Overview of treatment of non-transplant eligible MM
13 FIXED DURATION THERAPY (FDT) VS CONTINUOUS THERAPY (CT) IN MM PFS1 PFS2 Trials included: 2 MPR-R, 1 VMPT-VT Palumbo A. J Clin Oncol 2015;33:
14 FIXED DURATION THERAPY (FDT) VS CONTINUOUS THERAPY (CT) IN MM OS Palumbo A. J Clin Oncol 2015;33:
15 CURRENT TMWG GUIDELINE: INDUCTION THERAPY Non-novel agent-based regimen Melphalan-prednisolone (MP) (+) Cyclophosphamide-dexamethasone (CyD) (+) Pulse dexamethasone (+)
16 TD VS MP IN ELDERLY MM Ludwig H. Blood 2009;113:
17 ATTENUATED CTD VS MP IN ELDERLY MM PFS OS CTDa : higher rates of thromboembolic events, constipation, infection, and neuropathy than MP Morgan GJ. Blood 2011;118:
18 CURRENT TMWG GUIDELINE: INDUCTION THERAPY Novel agent-based regimen Melphalan-prednisolone-thalidomide (MPT) (+) Melphalan-prednisolone-bortezomib (VMP) (+) Bortezomib-dexamethasone (VD) (+) Continuous lenalidomide-dexamethasone (Rd) (+/-)
19 MPT VS MP IN ELDERLY MM Favours MPT Favours MP Fayers PM. Blood 2011;118:
20 MPT VS MP IN ELDERLY MM Favours MPT Favours MP Fayers PM. Blood 2011;118:
21 VISTA TRIAL: VMP VS MP IN ELDERLY MM Time to next therapy was longer with VMP than with MP (median 30.7 vs 20.5 months; P=0.001) San Miguel JF. J Clin Oncol 2012;31:
22 UPFRONT TRIAL: VD VS VMP VS VTP PFS OS Niesvizky R. J Clin Oncol 2015;33:
23 FIRST TRIAL: CONTINUOUS RD VS RD18 VS MPT yr PFS 2 33% 14% 13% 1 Benboubker L. N Engl J Med 2014;371: Facon T. J Clin Oncol 2015; Abstract 8524.
24 FIRST TRIAL: CONTINUOUS RD VS RD18 VS MPT12 Benboubker L. N Engl J Med 2014;371:
25 MPR/CPR VS RD INDUCTION THEN R VS RP MAINTENANCE PFS OS Magarotto V. Blood 2016;127:
26 MPR/CPR VS RD INDUCTION THEN R VS RP MAINTENANCE Outcomes MPR (n= 211) CPR (n=220) Rd (n = 212) ORR 71% 68% 74% CR 3% 0.5% 3% Median PFS 24 mo 20 mo 21 mo 4-year OS 65% 68% 58% Grade 3 hematological AE Grade 3 extra-hematologic AE Second primary malignancies 68% 32% 29% 31% 30% 30% 1.5% 1% 0% Magarotto V. Blood 2016;127:
27 CURRENT TMWG GUIDELINE: MAINTENANCE THERAPY Thalidomide maintenance only in non-high risk cytogenetics (+/-) Bortezomib maintenance (+/-) Lenalidomide maintenance (+/-)
28 THALIDOMIDE MAINTENANCE: MRC MYELOMA IX PFS OS Morgan GJ. Blood 2012;119:7-15.
29 THALIDOMIDE MAINTENANCE: MRC MYELOMA IX Adverse ifish: gain(1q), t(4;14), t(14;16), t(14;20), del(17p) PFS OS Morgan GJ. Blood 2012;119:7-15.
30 1 Niesvizky R. J Clin Oncol 2015;33: San Miguel JF. N Engl J Med 2008;359: San Miguel JF. J Clin Oncol 2012;31: UPFRONT STUDY: VD VS VTD VS VMP THEN BORTEZOMIB MAINTENANCE 1 VMP (VISTA Trial) 24 months 2 VMP (VISTA Trial) 56.4 months 3
31 VT OR VP MAINTENANCE AFTER VMP OR VTP 1 VMP (VISTA Trial) VMP (VISTA Trial) 24 months months 3 1 Mateos MV. Blood 2012;120: San Miguel JF. N Engl J Med 2008;359: San Miguel JF. J Clin Oncol 2012;31:
32 MPR-R VS MPR VS MP IN ELDERLY MM PFS OS Palumbo A. N Engl J Med 2012;366:
33 MPR-R VS MPT-T IN ELDERLY MM ECOG E1A06 TRIAL PFS OS p = p = Stewart AK. Blood 2015;126:
34 MPR-R VS MPT-T IN ELDERLY MM HOVON87/NMSG18 TRIAL PFS OS Zweegman S. Blood 2016;127:
35 MPR/CPR VS RD THEN R VS RP MAINTENANCE IN ELDERLY MM PFS OS Magarotto V. Blood 2016;127:
36 OUTLINE Overview of treatment for non-transplant eligible MM Current TMWG Guideline Update in non-transplant eligible MM induction treatment
37 UPDATE IN INDUCTION TREATMENT OF NON-TRANSPLANT ELIGIBLE MM Bortezomib and lenalidomide-based regimen VRd CyBorD VMP and Rd alternate or sequential
38 VRD VS RD IN NON-TRANSPLANT ELIGIBLE MM PFS OS Median 43 months Median 75 months 64 months 30 months ORR (CR rate) VRd 81.5% (15.7%) vs Rd 71.5% (8.4%) Age > 65 years VRd 48% vs Rd 38% Durie BG. Lancet 2017;389:
39 NCCN GUIDELINE V Primary therapy for non-transplant candidates Preferred regimens Bortezomib/lenalidomide/dexamethasone (1) Lenalidomide/low-dose dexamethasone* (1) Bortezomib/cyclophosphamide/dexamethasone** (2A) Other regimens Carfilzomib/lenalidomide/dexamethasone (2A) Carfilzomib/cyclophosphamide/dexamethasone (2A) Ixazomib/lenalidomide/dexamethasone (2A) Useful in certain circumstances Bortezomib/dexamethasone* (2A) *Elderly or frail patients may be treated with doublet regimens **Preferred initial treatment in patients with AKI
40 NCCN GUIDELINE V Maintenance therapy Preferred regimens Lenalidomide Other recommended regimens Bortezomib
41 PHASE II STUDY OF CY-BOR-D IN NEWLY DIAGNOSED MM 63 patients with mean age of 60 (38 75) years 14 patients (22%) did not have undergone ASCT ORR 89% with >VPPR 62% For patients completed 4 cycles: ORR 93% (>VGPR 67%) Median PFS 40.0 months 5-year PFS 42% and OS 70% Reeder CB. Br J Haematol 2014;167:563-5.
42 BORTEZOMIB-BASED INDUCTION IN NON-TRANSPLANT ELIGIBLE MM: RETROSPECTIVE SINGLE CENTER STUDY CyBorD (n = 42) VMP (n = 42) VD (n = 38) Age (median) P value Overall response rate (>PR) 95.2% 80.9% 76.3% >Very good partial response 76.1% 52.3% 26.3% Progression 33.3% 80.9% 78.9% Median PFS (months) Median OS (months) NS Median OS and PFS was longer for patients receiving continuous therapy more than 12 cycles - OS 56.8 vs. 31 months, p = PFS 21.1 vs months, p = Jimenez-Zepeda VH. Ann Hematol 2017;96:431 9.
43 SEQUENTIAL VS ALTERNATING ADMINISTRATION OF VMP AND RD IN ELDERLY MM Mateos MV. Blood 2016;127:
44 SEQUENTIAL VS ALTERNATING ADMINISTRATION OF VMP AND RD IN ELDERLY MM PFS OS Median PFS: VMP (VISTA) 24 months, Rd (FIRST) 25.5 months Mateos MV. Blood 2016;127:
45 UPDATE IN INDUCTION TREATMENT OF NON-TRANSPLANT ELIGIBLE MM Bortezomib and lenalidomide-based regimen Carfilzomib-based regimen
46 CARFILZOMIB INDUCTION IN NON-TRANSPLANT ELIGIBLE MM Regimen N Response rate Survival outcomes CMP 1 44 ORR 90% VGPR 58% CR 12% after 9 cycles CRd 2 23 ncr 82% after 8 cycles 100% after 16 cycles scr 35% after 8 cycles 78% after 16 cycles CCyd 3 58 ORR 95% VGPR 71% ncr 49% scr 20% after 9 cycles Median PFS 21 months 3-year OS 80% 3-year PFS 79.6% 3-year OS 100% 2-year PFS 76% 2-year OS 87% CMP: carfilzomib-melphalan-prednisolone; CRd: carfilzomib-lenalidomide-dexamethasone; CCyd: carfilzomib-cyclophosphamide-dexamethasone 1 Moreau P. Blood 2015;125: Dytfeld D. Haematologica 2014;99:e Bringhen S. Blood 2014;124:63-9.
47 UPDATE IN INDUCTION TREATMENT OF NON-TRANSPLANT ELIGIBLE MM Bortezomib and lenalidomide-based regimen Carfilzomib-based regimen Ixazomib-based regimen
48 IRD-IXAZIMIB MAINTENANCE IN NEWLY DIAGNOSED MM Phase 1/2 study: 65 patients (median age 66 years) 1-year PFS and OS 88 and 94%, respectively Grade 3-4 peripheral neuropathy 6% Kumar SK. Lancet Oncol 2014;15:
49 NCCN GUIDELINE V Primary therapy for non-transplant candidates Preferred regimens Bortezomib/lenalidomide/dexamethasone (1) Lenalidomide/low-dose dexamethasone* (1) Bortezomib/cyclophosphamide/dexamethasone** (2A) Other regimens Carfilzomib/lenalidomide/dexamethasone (2A) Carfilzomib/cyclophosphamide/dexamethasone (2A) Ixazomib/lenalidomide/dexamethasone (2A) Useful in certain circumstances Bortezomib/dexamethasone* (2A) *Elderly or frail patients may be treated with doublet regimens **Preferred initial treatment in patients with AKI
50 UPDATE IN INDUCTION TREATMENT OF NON-TRANSPLANT ELIGIBLE MM Bortezomib and lenalidomide-based regimen Carfilzomib-based regimen Ixazomib-based regimen Elotuzumab-based regimen
51 VRD-ELOTUZUMAB IN NEWLY DIAGNOSED MM Phase I study: only safety data available VRd-Elo induction for 8 cycles then dose-attenuated VRd-Elo maintenance Median patient age 67 years (range 56 79) The most common AEs Fatigue (100%) Peripheral sensory neuropathy (83%) Edema (83%) Lymphopenia (66%) with 1 DLT (grade 4 lymphopenia) Leukopenia (50%) Usmani SZ. Blood Cancer J 2015;5:e334.
52 UPDATE IN INDUCTION TREATMENT OF NON-TRANSPLANT ELIGIBLE MM Bortezomib and lenalidomide-based regimen Carfilzomib-based regimen Ixazomib-based regimen Elotuzumab-based regimen Daratumumab-based regimen
53 DARA-VMP VS VMP IN NON-TRANSPLANT ELIGIBLE MM Phase III ALCYONE study: 706 patients Receive 9 cycles of Daratumumab combined with VMP then daratumumab once every 4 weeks until PD VMP alone The study met primary endpoint of improving PFS at a preplanned interim analysis Median PFS NR vs months (HR = 0.50, 95% CI ; P < ) Data will be presented in ASH cited 6 th November, 2017.
54 CONCLUSIONS Treatment of elderly MM should be individualized based on patient s factor (including frailty) and disease s factor Continuous therapy is now recommended more than fixed-duration therapy New combination with novel agents are promising for treatment of elderly MM
55 CONCLUSIONS Treatment of elderly MM should be individualized based on patient s factor (including frailty) and disease s factor Continuous therapy is now recommended more than fixed-duration therapy New combination with novel agents are promising for treatment of elderly MM Balance between efficacy and toxicity
56 THANK YOU FOR YOUR ATTENTION
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