Table 4. Clinical studies in patients with multiple myeloma receiving combination regimens that include a proteasome inhibitor and an IMiD.
Reference Response criteria Study type | Treatment arm | n | Maximal response (%) | PFS/TTP (median, moa/rate, %) | OS (median, moa/rate, %) | |
---|---|---|---|---|---|---|
Frontline transplant eligible | ||||||
CR induction | Overall | 3-yr PFS | 3 yr | |||
Cavo et al.19 mEBMT Ph 3 | VTD induction/consolidation TD induction/consolidation | 241 239 | 19 5 P<0.0001 | 58 41 P=0.0001 | 68 56 P=0.0057 | 86 84 P=0.3 |
CR induction | Transplant | mPFS | — | |||
Moreau et al.20 IMWG Ph 3 | vtD inductionVD induction | 13 12 P=0.74 | 29 31 P=0.77 | 26 30 P=0.22 | ||
Transplant ineligible | ||||||
CR induction | mPFS | 3-yr PFS | 3 yr | |||
Palumbo et al.65 IMWG Ph 3 | VMPT induction →VT maint VMP induction | 254 257 | 38 24 P<0.001 | NR 27.3 | 56 41 P=0.008 | 89 87 P=0.77 |
CR induction | mPFS | 3 yr | ||||
Mateos et al.21 mEBMT Ph 3 | VTP induction→VT or VP maint VMP induction→VT or VP maint | 130 130 | 28 20 P=0.2 | 25 34 P=0.1 | 65 74 P=0.3 | |
Transplant eligible/ineligible | ||||||
CR overall | 18-mo PFS | 18 mo | ||||
Richardson et al.22 mIMWG Ph 1/2 | VRD induction→VRD maint or HD-ASCT | 66 | 29 | 75 | 97 | |
sCR overall | 2-yr PFS | |||||
Jakubowiak et al.24 mIMWG Ph 1/2 | CRd induction→CRd maint or HD-ASCT | 53 | 42 | 92 | — | |
CR overall | ||||||
Kumar et al.25 mIMWG Ph 1/2 | IRd→ixazomib maint | 65 | 18 | — | — | |
Relapsed | ||||||
CR overall | mTTP | 24 mo | ||||
Garderet et al.23 mEBMT Ph 3 | VTD TD | 135 134 | 25 14 P=0.024 | 19.5 13.8 P=0.001 | 71 65 P=0.093 |
Abbreviations: CRd, carfilzomib, lenalidomide, low-dose dexamethasone; HD-ASCT, high-dose therapy with autologous stem cell transplant; IRd, ixazomib (MLN9708), lenalidomide, low-dose dexamethasone; maint, maintenance therapy; mEBMT, modified European Group for Blood and Marrow Transplantation; mIMWG, modified International Myeloma Working Group; mo, months; mOS, median overall survival; mPFS, median progression-free survival; mTTP, median time to progression; TD, thalidomide, dexamethasone; VGPR, very good partial response; VMP, bortezomib, melphalan, prednisone; vtD, low-dose bortezomib, thalidomide with dexamethasone; VTD, bortezomib, thalidomide, dexamethasone; VTP, bortezomib, thalidomide, prednisone; yr, years.
Conversion to months for studies reporting other time increments.