Table 2.
Patient Characteristics
| Factor | All Patients (n=121) | Arm 1 (n=64) | Arm 2 (n=57) | P-value* |
|---|---|---|---|---|
| Age ≥65 years (n=121) | 52% | 48% | 56% | 0.467 |
| Gender (n=121) | 0.584 | |||
| Female | 45% | 48% | 42% | |
| Male | 55% | 52% | 58% | |
| Performance Status >1 (n=121) | 4% | 3% | 5% | 0.666 |
| Myeloma Isotype (n=115) | ||||
| IgG | 52% | 59% | 44% | 0.137 |
| IgA | 15% | 8% | 22% | 0.039 |
| Light Chain Only | 15% | 15% | 15% | 1 |
| Creatinine Clearance <60 ml/min (n=121) | 34% | 36% | 32% | 0.701 |
| LDH ≥190 U/L (n=119) | 48% | 49% | 46% | 0.855 |
| Hemoglobin <10 g/dL (n=121) | 17% | 23% | 11% | 0.091 |
| Platelet Count <150 X 10^9/L (n=121) | 2% | 2% | 2% | 1 |
| ISS Disease Stage (n=121) | ||||
| Stage I | 35% | 31% | 39% | 0.447 |
| Stage II | 40% | 47% | 33% | 0.142 |
| Stage III | 25% | 22% | 28% | 0.528 |
| 4–6 Prior Lines of Therapy** (n=121) | 24% | 22% | 26% | 0.671 |
| Prior Therapy*** (n=120) | ||||
| Steroids | 99% | 100% | 99% | |
| IMiDs | 88% | 88% | 88% | |
| Lenalidomide | 84% | 86% | 82% | |
| Pomalidomide | 9% | 9% | 9% | |
| Thalidomide | 14% | 9% | 19% | |
| Proteasome Inhibitors | 84% | 88% | 80% | |
| Alkylators (Non-transplant) | 36% | 39% | 33% | |
| Stem Cell Transplant | 41% | 40% | 41% | |
| Other | 18% | 19% | 16% | |
| Refractory to Bortezomib** (n=121) | 50% | 50% | 49% | 1 |
| Serum M Spike >3 g/dL (n=120) | 16% | 20% | 11% | 0.211 |
| BM Plasma Cells >60% (n=119) | 21% | 22% | 20% | 0.823 |
P-values computed using Fisher’s exact test and representing a comparison between groups, not against the overall population
Stratification Factor
Prior Therapy (patients could have had more than one of these agents previously): IMiDs included thalidomide, lenalidomide and pomalidomide; Proteasome inhibitors included bortezomib and ixazomib; Alkylators included cyclophosphamide and melphalan in the non-transplant setting, Others included agents that were used in <5% patients on either arm and included monoclonal antibodies (monoclonal antibodies used as prior therapy in 7 cases).
Number of patients on whom data was available for each characteristic are shown in parenthesis in the respective rows.
LDH=Lactate dehydrogenase, M spike=Monoclonal spike, BM=Bone marrow