Table 2.
Outcomes of patients with +1q in randomized studies of newly diagnosed multiple myeloma.
| Trial | Study treatments | N with 1q | Outcomes by 1q status |
|---|---|---|---|
| HOVON65/GMMG-HD471,112 |
A: VAD → ASCT → mThal B: PAD → ASCT → mBort |
Total +1q: 111 (32.3%) Gain(1q): 95 (27.6%) Amp(1q): 16 (4.7%) |
96 month OS (+1q vs no +1q) Arm A: 28% vs 55% (p < 0.001) Arm B: 36% vs 62% (p = 0.006) OS HR by 1q copy number Gain(1q) vs normal 1q: 1.65 (p = 0.0010) Amp(1q) vs normal 1q: 2.48 (p = 0.0062) |
| TT217* |
A: no Thalidomide B: with Thalidomide |
Total +1q: 205 (42.8%) Gain(1q): 117 (24%) Amp(1q): 88 (18%) |
+1q vs normal 1q by treatment arm Arm A: 5 yr OS 55% vs 73% Arm B: 5 yr OS 49% vs 84% Outcomes by copy number Gain(1q) vs normal 1q: 5 yr OS 53% vs 78%, p < 0.001 Gain(1q) vs amp(1q): 5 yr OS 53% vs 50%, p = 0.453 |
| Myeloma IX60,69† |
A: CTD → ASCT B: CVAD → ASCT C: CTDa → mThal vs none D: MP → mThal vs none |
Total +1q: 340 (39.1%) |
+1q vs normal 1q Median PFS: 13.8mo vs 22.1mo; HR 1.53 (p = 6.7 × 10−9) Median OS: 31.0mo vs 54.8mo; HR 1.61 (p = 1.81 × 10−8) |
| Myeloma XI69‡ |
A: CTD → ASCT → mR vs none B: CRD → ASCT → mR vs none C: KCRD → ASCT → mR vs none D: CTDa → mR vs none E: CRDa → mR vs none |
Total +1q: 357 (34.5%) Gain(1q): 277 (26.7%) Amp(1q): 80 (7.7%) |
Gain(1q) vs normal 1q Median PFS: 21.8mo vs 30.1mo HR 1.56 (p = 3.53 × 10−7) 24mo OS: 77.5% vs 83.5% HR 1.67 (p = 3.30 × 10−5) Gain(1q) vs Amp(1q) Median PFS: 21.8 mo vs 19.4 mo; HR 0.91 (p = 0.54) 24 mo OS: 77.5% vs 63.8%; HR 1.36 (p = 0.09) |
| FORTE70 |
A: KCd → ASCT → R vs KR B: KRd → ASCT → R vs KR C: KRd12 → R vs KR |
Total +1q: 181 (45.3%) Gain(1q): 129 (32.3%) Amp(1q): 52 (13.0%) |
Gain(1q) vs normal 1q Median PFS: 53 mo vs NR; HR 1.65 (95% CI 1.14–2.37) 3 yr OS: 88% vs 94%; HR 1.88 (95% CI 0.98–3.58) Amp(1q) vs Gain(1q) Median PFS: 21.8 mo vs 53 mo; HR 1.84 (95% CI 1.21–2.81) 3 yr OS: 55% vs 88%; HR 1.84 (95% CI 1.73–5.68) Amp(1q) vs normal 1q Median PFS: 21.8 mo vs NR; HR 3.04 (95% CI 1.99–4.65) 3 yr OS: 55% vs 94%; HR 5.88 (95% CI 3.10–11.17) |
| S1211101 |
A: RVd → m. RVd B: Elo-RVd → m. Elo-RVd |
Total +1q: 47 (47%) |
Arm A vs Arm B Median PFS: 41 mo vs 32 mo; HR 0.761 (80% CI 0.459–1.261) Overall survival (all patients, multivariate analysis) +1q21 vs no 1q21: HR 0.776 (80% CI 0.388–1.552) |
*The TT2 study reported all patients with chromosome 1 abnormalities as Amp1q21, but reported copy number separately.
†Patients assigned to intensive (randomized to A or B) or non-intensive (randomized to C or D) at discretion of investigator.
‡Patients were assigned to intensive (randomized to A or B; arm C added with a protocol amendment) or non-intensive (randomized to D or E) at discretion of investigator. If patients achieved only a partial or minimal response after induction, they were also randomized to intensification with VCD versus no intensification.