Table 2.
Trial | Agent or Regimen |
Target Population |
Enrolled Population (% with 1, 2, 3 prior lines) |
Key Exclusion Criteria |
Adverse Events Increased in Experimental Arm* |
---|---|---|---|---|---|
PANORAMA1 | Panobinostat/Bortezomib/dex | Relapsed or refractory with 1–3 prior therapies | 51% / 32% / 17% | Primary refractory or bortezomib-refractory myeloma | Diarrhea, fatigue, nausea, peripheral edema, anorexia, pyrexia, vomiting, thrombo-cytopenia, leukopenia, neutropenia, and anemia |
Placebo/Bortezomib/dex | 52% / 28% / 20% | ||||
ASPIRE | Carfilzomib/Lenalidomide/dex | Relapsed disease after 1–3 prior lines of therapy | 46.5% / 53.3% with 2 or 3 lines | Bortezomib-refractory disease excluded. RD allowed if not most recent tx, and no progression during first three RD months. | Cough and hypokalemia |
Lenalidomide/dex | 39.6% / 60.1% with 2 or 3 lines | ||||
SIRIUS | Daratumumab | Refractory disease with ≥3 lines including PI & IMiD, or refractory to both. | Median of 5 (range 2–14) | None | Not applicable (non-randomized study) |
TOURMALINE 1 | Ixazomib/Lenalidomide/dex | Relapsed or refractory with 1–3 prior therapies | 62% / 27% / 11% | Patients with disease refractory to lenalidomide or a PI | Thrombocytopenia, rash, and vomiting |
Placebo/Lenalidomide/dex | 60% / 31% / 9% | ||||
ELOQUENT-2 | Elotuzumab/Lenalidomide/dex | Relapsed after 1–3 prior therapies | 47% with 1 regimen, 37% with 2, 16% with ≥3 | Prior len permitted (in ≤10%) if achieved ≥PR, did not progress on or within 9 months of therapy, did not discontinue due to ≥grade 3 AE, had <9 cycles, had ≥9 months between last dose & PD. | Pyrexia, diarrhea, cough |
Lenalidomide/dex | 49% with 1 regimen, 35% with 2, 16% with ≥3 | ||||
ENDEAVOR | Carfilzomib/dex | Patients with relapsed or refractory myeloma after 1–3 prior lines of therapy. | 49.8% / 50.2% with 2 or 3 lines | Bortezomib or carfilzomib allowed if these were tolerated, induced a ≥PR before progression, and if patients had a six-month PI-free period | Anemia, dyspnea, pyrexia, cough, hypertension, and muscle spasms |
Bortezomib/dex | 49.2% / 50.8% with 2 or 3 lines | ||||
CASTOR | Daratumumab/Bortezomib/dex | Relapsed or refractory myeloma after ≥1 prior line(s) of therapy. | 48.6% / 27.9% / 14.7% / 8.8% >3 prior lines | Primary refractory disease. Patients refractory or intolerant to bortezomib, or another proteasome inhibitor. | Thrombocytopenia, cough |
Bortezomib/dex | 45.7% / 30.0% / 13.0% / 11.3% >3 prior lines | ||||
POLLUX | Daratumumab/Lenalidomide/dex | Relapsed or refractory myeloma after ≥1 prior line of therapy | Median of 1 (range 1–11) | Lenalidomide-refractory or intolerant disease | Neutropenia, diarrhea, upper respiratory infection, cough |
Lenalidomide/dex | Median of 1 (range 1–8) |
Abbreviations: AE, adverse event; dex, dexamethasone, IMiD, immunomodulatory drug; len, lenalidomide; PD, disease progression; PI, proteasome inhibitor; PR, partial remission; RD, lenalidomide a›nd dexamethasone; tx, therapy
Adverse events of all grades are listed whose overall incidence was increased in the experimental arm by at least an absolute value of 10% compared with the control arm, where applicable