Table 2.
Characteristics and response of patients receiving mCBAD (n = 140).
| Characteristics | NDMM (n=13; 9%) | PCL (n=11; 8%) | RRMM (n=116; 83%) |
|---|---|---|---|
| Gender (male), n(%) | 11 (84.6) | 9 (81.8) | 71 (61.2) |
| Age at diagnosis, median (range), years | 56 (45 – 72) | 62 (36 – 79) | 55 (22 – 79) |
| MM subtype, n(%) | |||
| IgA lambda | 2 (15) | 2 (18) | 14 (12) |
| IgA kappa | 1 (8) | 1 (9) | 18 (15) |
| IgG kappa | 4 (31) | 1 (9) | 45 (39) |
| IgG lambda | 2 (15) | 3 (27) | 22 (19) |
| IgD lambda | 0 | 0 | 1 (0.8) |
| Lambda light chain only | 2 (15) | 2 (18) | 6 (5) |
| Kappa light chain only | 2 (15) | 1 (9) | 10 (9) |
| Non-secretory | 0 | 1 (9) | 0 |
| Disease characteristics at initial diagnosis, n(%) | |||
| Hypercalcemia | 7 (53.8) | 4 (36.4) | 26 (23.6) |
| Lytic bone lesions | 10 (76.9) | 9 (81.8) | 95 (81.9) |
| Anemia | 13 (100) | 10 (90.9) | 82 (74.5) |
| Kidney failure, creatinine ≥ 2 mg/dL | 9 (69.2) | 7 (63.6) | 34 (30.6) |
| Bone marrow plasma cells > 60% | 9 (69.2) | 10 (90.9) | 67 (59.3) |
| ISS stage*, n(%) | |||
| I | 0 | 1 (14.3) | 26 (28.6) |
| II | 2 (16.7) | 0 | 24 (26.4) |
| III | 10 (83.3) | 6 (85.7) | 41 (45.1) |
| FISH studies**, n(%) | |||
| t(4,14) | 1 (8.3) | 1 (11.1) | 9 (10) |
| t(14,16) | 0 | 0 | 2 (2.2) |
| Deletion 17p | 1 (8.3) | 3 (33.3) | 23 (25.6) |
| Number of previous lines of therapy | NA | ||
| 1 | 1 (9.1) | 26 (22.4) | |
| 2 | 1 (9.1) | 33 (28.4) | |
| 3 | 2 (18.2) | 26 (22.4) | |
| ≥ 4 | 0 | 31 (26.7) | |
| Previous ASCT, n(%) | - | 2 (18.2) | 56 (48.7) |
| Number of previous lines of therapy | |||
| < 3 regimen | NA | 2 (50) | 59 (50.7) |
| ≥ 3 regimen | 2 (50) | 57 (49.1) | |
| Number of prior therapies received, (%) | |||
| 0 | 13 (100) | 7 (63.6) | 0 |
| 1 | 0 | 1 (9.1) | 26 (22.4) |
| 2 | 0 | 1 (9.1) | 33 (28.4) |
| 3 | 0 | 2 (18.2) | 26 (22.4) |
| 4 | 0 | 0 | 14 (12.1) |
| 5 | 0 | 0 | 6 (5.2) |
| 6 | 0 | 0 | 4 (3.4) |
| 7 | 0 | 0 | 3 (2.6) |
| 8 | 0 | 0 | 3 (2.6) |
| 12 | 0 | 0 | 1 (0.9) |
| Time from diagnosis to start of mCBAD (months); median (range) | NA | 1 | |
| < 3 regimen | 0.13 and 112*** | 9 (0.33 – 86.3) | |
| ≥ 3 regimen | 9 and 52*** | 46.4 (7.23 – 744.77) | |
| Previous treatment | NA | i | |
| Bortezomib | 4 (36.4) | 109 (94) | |
| Lenalidomide/Thalidomide | 3 (27.3) | 99(85) | |
| Bortezomib plus lenalidomide | 1 (9.1) | 93 (80.2) | |
| Carfilzomib | 0 | 28 (24) | |
| Pomalidomide | 0 | 13 (11.2) | |
| ECOG-PS before mCBAD | i | ||
| 0–1 | 11 (84.6) | 6 (54.5) | 93 (80.1) |
| 2 | 2 (15.4) | 1 (9) | 18 (15.5) |
| 3–4 | 0 | 2 (18.1) | 2 (1.7) |
| Clinical rationale for use of mCBAD in NDMM | NA | NA | |
| High tumor burden with renal failure | 5 (38.5) | ||
| High tumor burden without renal failure | 1 (7.7) | ||
| Rapid change in clinical status while awaiting treatment | |||
| - Rapid increase in tumor burden with concurrent kidney failure | 4 (30.8) | ||
| -Transformation to PCL | 2(15.3) | ||
| Simultaneous diagnosis of MM and aggressive B cell lymphoma | 1 (7.7) | ||
| Number of mCBAD cycles received, (%) | 1 | ||
| ≤ 2 | 11 (84.6) | 9 (81.8) | 100 (86.2) |
| ≥ 3 | 2 (14.4) | 2 (18.2) | 16 (13.8) |
| Number of mCBAD cycles received, (%) | 1 | ||
| 1 | 8 (61.5) | 6 (63.6) | 57 (49.1) |
| 2 | 3 (23.1) | 3 (27.3) | 43 (37.1) |
| 3 | 1 (7.7) | 0 | 16 (13.8) |
| 4 | 1 (7.7) | 0 | 0 |
| 6 | 0 | 1 (9.1) | 0 |
| Subsequent transplant after treatment | |||
| No transplant | 3 (23.1) | 7 (63.7) | 71 (61.2) |
| Autologous Stem cell transplant | 9 (69.2) | 4 (36.3) | 42 (36.2) |
| Allogeneic Stem cell transplant | 1 (7.1) | 0 | 3 (2.6) |
| Maintenance Therapy | 9 (69.2) | 5 (45.5) | 54 (46.5) |
| Lenalidomide-Dex | 7 (53.8) | - | 24 (20.7) ¶ |
| PI-Dex | - | 2 (18.2) ‡ | 11 (9.5) ¶¶ |
| VRD | 2 (15.4) † | 2 (18.2) | 5 (4.3) ¶¶¶ |
| VCD | - | 1 (9.1) | 7 (6) |
| KRD/KCD | - | - | 2 (1.7)/1 (0.9) |
| Other | - | - | 4 (3.4) § |
| Type of response¥ | |||
| ORR | 13(100) | 10 (100) | 91 (85) |
| CR | 3 (23.1) | 1 (10) | 8 (7.5) |
| VGPR | 3 (23.1) | 2 (20) | 19 (17.8) |
| PR | 7 (53.8) | 7 (70) | 64 (59.8) |
| SD | 0 | 0 | 3 (2.8) |
| PD | 0 | 0 | 13 (12.1) |
mCBAD: modified Cyclophosphamide, Bortezomib, Doxorubicin, and Dexamethasone; MM: multiple myeloma; NDMM: newly diagnosed multiple myeloma; PCL: plasma cell leukemia; RRMM: relapsed refractory multiple myeloma; ISS: international staging system; FISH: fluorescent in situ; ASCT: autologous stem cell transplant; ECOG-PS: eastern cooperative oncology group - performance status, PI: proteasome inhibitor; VRD: Bortezomib, Lenalidomide, Dexamethasone; VCD: Bortezomib, Cyclophosphamide, Dexamethasone; KRD: Carfilzomib, Lenalidomide, Dexamethasone; KCD: Carfilzomib, Cyclophosphamide, Dexamethasone; ORR: overall response rate; CR: complete response; VGPR: very good partial response; PR: partial response; SD: stable disease; PD: progressive disease.
ISS staging data was available for 110 patients.
FISH studies were available for 111 patients.
2 patients each had either <3 lines or ≥ 3 lines of therapy. The other patients with PCL were newly diagnosed and had not received any therapies prior to mCBAD.
One patient received ixazomib instead of bortezomib and one patient received Elotuzumab in addition to VRD.
one patient received bortezomib and one patient received carfilzomib
4 patients received thalidomide maintenance
6 patients received bortezomib, 4 patients received carfilzomib, and 1 patients received ixazomib
One patient received thalidomide instead of lenalidomide
One patient received cyclophosphamide, one patient received a combination of daratumumab, lenalidomide, dexamethasone; one patient received carfilzomib, panobinostat, dexamethasone; one patient received an aurora A kinase inhibitor within a clinical trial.
10 patients with PCL were evaluable for response and 107 patients of RRMM patients were evaluable for response