Table 3.
MMRMs Analysis of Change From Baseline in PRO Scales (HRQoL Analysis Population)
| Item/Domain | EPd: N, LS Mean (95% CI) | Pd: N, LS Mean (95% CI) | Treatment Difference LS Mean (95% CI)a | Treatment Difference P Value |
MID |
|---|---|---|---|---|---|
| MDASI-MMb | |||||
| Total symptom severity | 48, 0.5 (0.1–0.9) | 40, 0.4 (−0.1 to 0.9) | 0.1 (−0.5 to 0.6) | 0.811 | 0.4 |
| Core symptom severity | 48, 0.4 (−0.1 to 0.8) | 40, 0.3 (−0.2 to 0.9) | 0.1 (−0.5 to 0.6) | 0.846 | 0.5 |
| Module symptom severity | 47, 0.5 (0.1–0.9) | 40, 0.4 (−0.1 to 0.9) | 0.1 (−0.4 to 0.6) | 0.597 | 0.7 |
| Item 1: Pain | 48, 0.2 (−0.6 to 0.9) | 40, 0.2 (−0.7 to 1.1) | −0.1 (−1.1 to 0.9) | 0.884 | 1.3 |
| Item 2: Fatigue | 48, 0.9 (0.1–1.7) | 40, 0.9 (−0.1 to 1.8) | 0.0 (−1.0 to 1.0) | 0.987 | 1.3 |
| Item 20: Bone pain | 47, 0.1 (−0.8 to 0.9) | 40, −0.2 (−1.1 to 0.8) | 0.2 (−0.9 to 1.3) | 0.695 | 1.5 |
| Symptom interference | 47, 0.5 (−0.2 to 1.2) | 40, 0.8 (0.0–1.5) | −0.3 (−1.1 to 0.5) | 0.462 | 0.7 |
| Activity interference | 47, 0.6 (−0.2 to 1.3) | 40, 0.8 (−0.1 to 1.6) | −0.2 (−1.0 to 0.7) | 0.708 | 0.8 |
| Affective interference | 47, 0.2 (−0.4 to 0.9) | 40, 0.6 (−0.2 to 1.3) | −0.4 (−1.2 to 0.4) | 0.344 | 0.8 |
| EQ-5D-3Lc | |||||
| Utility index | 54, −0.005 (−0.073 to 0.063) | 50, −0.053 (−0.130 to 0.023) | 0.048 (−0.032 to 0.129) | 0.237 | 0.08 |
| VAS | 52, 1.4 (−3.6 to 6.4) | 48, −3.3 (−8.7 to 2.2) | 4.7 (−0.9 to 10.2) | 0.098 | 7 |
Includes all data up to cycle 13 (where both treatment arms had ≥10 patients).
A treatment difference that exceeds the MID indicates a clinically meaningful difference between treatment arms.
Score ranges from 0 to 10, with a higher score indicating greater symptom severity/interference. A positive LS mean change from baseline indicates worsening and a positive LS mean treatment difference indicates greater symptom burden/interference for EPd.
Utility index score ranges from 1 (full health) to 0 (death), with negative scores (to −0.59) reflecting health states valued as worse than death. VAS score ranges from 0 to 100. A positive LS mean change from baseline indicates improvement and a positive LS mean treatment difference indicates better HRQoL for EPd.
CI = confidence interval; EPd = elotuzumab + pomalidomide + dexamethasone; EQ-5D-3L = 3-level EuroQol 5 dimension; HRQoL = health-related quality of life; LS = least squares; MDASI-MM = MD Anderson Symptom Inventory for Multiple Myeloma; MID = minimally important difference; MMRM = mixed models for repeated measures; Pd = pomalidomide + dexamethasone; PRO = patient-reported outcome; VAS = visual analog scale.