Patient demographics, disease characteristics, and treatment history at baseline (all enrolled patients)
| . | Mezagitamab cohort . | ||||||
|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | |
| Median age, y (range) | 64.5 (53-75) | 69.0 (64-74) | 67.5 (56-76) | 67.0 (59-85) | 64.0 (50-72) | 64.0 (52-74) | 66.0 (50-85) |
| Male sex, n (%) | 2 (50) | 2 (67) | 10 (85) | 14 (64) | 3 (100) | 2 (33) | 33 (66) |
| Race, n (%) | |||||||
| White | 1 (25) | 0 | 9 (75) | 15 (68) | 3 (100) | 3 (50) | 31 (62) |
| Black or African American | 2 (50) | 2 (67) | 0 | 3 (14) | 0 | 2 (33) | 9 (18) |
| Other | 0 | 0 | 2 (17) | 1 (5) | 0 | 0 | 3 (6) |
| Not reported | 1 (25) | 1 (33) | 1 (8) | 3 (14) | 0 | 1 (17) | 7 (14) |
| ECOG performance status, n (%) | |||||||
| 0 | 2 (50) | 1 (33) | 5 (42) | 2 (9) | 0 | 3 (50) | 13 (26) |
| 1 | 2 (50) | 2 (67) | 7 (58) | 19 (86) | 3 (100) | 3 (50) | 36 (72) |
| 2 | 0 | 0 | 0 | 1 (5) | 0 | 0 | 1 (2) |
| Median time from initial diagnosis, mo (range) | 108.3 (29.4-129.9) | 96.1 (43.1-165.3) | 70.8 (30.5-163.8) | 95.3 (16.0-272.2) | 83.1 (50.7-147.1) | 110.4 (25.7-384.7) | 94.8 (16.0-384.7) |
| MM type at initial diagnosis, n (%) | |||||||
| IgG | 4 (100) | 3 (100) | 6 (50) | 15 (68) | 3 (100) | 5 (83) | 36 (72) |
| IgA | 0 | 0 | 5 (42) | 6 (27) | 0 | 1 (17) | 12 (24) |
| Light chain only | 0 | 0 | 1 (8) | 1 (5) | 0 | 0 | 2 (4) |
| ISS stage at study entry, n (%) | |||||||
| I | 3 (75) | 1 (33) | 5 (42) | 6 (27) | 2 (67) | 1 (17) | 18 (36) |
| II | 0 | 1 (33) | 3 (25) | 10 (45) | 1 (33) | 2 (33) | 17 (34) |
| III | 1 (25) | 0 | 4 (33) | 4 (18) | 0 | 2 (33) | 11 (22) |
| Missing∗ | 0 | 1 (33) | 0 | 2 (10) | 0 | 1 (17) | 4 (8) |
| Median corrected calcium, mmol/L (range) | 2.3 (2.3-2.4) | 2.3 (2.2-2.3) | 2.4 (2.2-2.8) | 2.3 (2.2-2.6) | 2.3 (2.2-2.6) | 2.3 (2.2-2.4) | 2.3 (2.2-2.8) |
| Median hemoglobin, g/L (range) | 125 (106-138) | 118 (104-126) | 124.5 (83-153) | 121 (89-145) | 107 (107-122) | 119 (110-152) | 121 (83-153) |
| Median creatinine clearance, mL/min (range) | 83 (44-116) | 71 (52-77) | 86 (30-134) | 81 (31-143) | 97 (91-117) | 107 (56-144) | 86 (30-144) |
| Creatinine clearance category, n (%) | |||||||
| 30 to <60 mL/min | 1 (25) | 1 (33) | 3 (25) | 6 (27) | 0 | 1 (17) | 12 (24) |
| 60 to <90 mL/min | 1 (25) | 2 (67) | 3 (25) | 8 (36) | 0 | 1 (17) | 15 (30) |
| ≥90 mL/min | 2 (50) | 0 | 6 (50) | 8 (36) | 3 (100) | 4 (67) | 23 (46) |
| Lytic bone lesions, n (%) | n = 3 | n = 3 | n = 11 | n = 21 | n = 3 | n = 6 | N = 47 |
| Yes | 3 (100) | 2 (67) | 7 (64) | 12 (57) | 1 (33) | 2 (33) | 27 (57) |
| No | 0 | 1 (33) | 4 (36) | 8 (38) | 2 (67) | 4 (67) | 19 (40) |
| Indeterminate | 0 | 0 | 0 | 1 (5) | 0 | 0 | 1 (2) |
| Plasmacytomas, n (%) | n = 1 | n = 0 | n = 2 | n = 5 | n = 1 | n = 0 | N = 9 |
| Yes | 0 (9) | 0 | 0 | 1 (20) | 1 (100) | 0 | 2 (22) |
| No | 1 (100) | 0 | 2 (100) | 4 (80) | 0 | 0 | 7 (78) |
| Chromosomal aberrations, n (%) | n = 4 | n = 3 | n = 11 | n = 21 | n = 3 | n = 6 | N = 48 |
| High-risk cytogenetics† | 0 | 1 (33) | 4 (36) | 6 (29) | 1 (33) | 3 (50) | 15 (31) |
| Standard-risk cytogenetics | 4 (100) | 2 (67) | 7 (64) | 15 (71) | 2 (67) | 3 (50) | 33 (69) |
| Median number of prior lines of therapy, (range) | 4.0 (2-7) | 3.0 (3-5) | 3.0 (2-12) | 3.0 (2-16) | 4 (3-4) | 4 (2-5) | 3.5 (2-16) |
| Prior treatment, n (%) | |||||||
| Autologous stem cell transplant | 4 (100) | 3 (100) | 10 (83) | 17 (77) | 3 (100) | 6 (100) | 43 (86) |
| Alkylating agent | 4 (100) | 3 (100) | 12 (100) | 20 (91) | 3 (100) | 6 (100) | 48 (96) |
| Anti-CD38 antibody | 1 (25) | 0 | 3 (25) | 7 (32) | 0 | 0 | 11 (22) |
| IMiD | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| PI | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| Refractory status, n (%)‡ | |||||||
| To anti-CD38 antibody | 0 | 0 | 1 (8) | 5 (23) | 0 | 0 | 6 (12) |
| To either an IMiD or a PI | 4 (100) | 3 (100) | 10 (83) | 22 (100) | 3 (100) | 5 (83) | 47 (94) |
| To both an IMiD and a PI | 3 (75) | 1 (33) | 8 (67) | 17 (77) | 0 | 1 (17) | 30 (60) |
| To last line of therapy | 4 (100) | 2 (67) | 10 (83) | 18 (82) | 3 (100) | 4 (67) | 41 (82) |
| To any line of therapy | 4 (100) | 3 (100) | 10 (83) | 22 (100) | 3 (100) | 5 (83) | 47 (94) |
| . | Mezagitamab cohort . | ||||||
|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | |
| Median age, y (range) | 64.5 (53-75) | 69.0 (64-74) | 67.5 (56-76) | 67.0 (59-85) | 64.0 (50-72) | 64.0 (52-74) | 66.0 (50-85) |
| Male sex, n (%) | 2 (50) | 2 (67) | 10 (85) | 14 (64) | 3 (100) | 2 (33) | 33 (66) |
| Race, n (%) | |||||||
| White | 1 (25) | 0 | 9 (75) | 15 (68) | 3 (100) | 3 (50) | 31 (62) |
| Black or African American | 2 (50) | 2 (67) | 0 | 3 (14) | 0 | 2 (33) | 9 (18) |
| Other | 0 | 0 | 2 (17) | 1 (5) | 0 | 0 | 3 (6) |
| Not reported | 1 (25) | 1 (33) | 1 (8) | 3 (14) | 0 | 1 (17) | 7 (14) |
| ECOG performance status, n (%) | |||||||
| 0 | 2 (50) | 1 (33) | 5 (42) | 2 (9) | 0 | 3 (50) | 13 (26) |
| 1 | 2 (50) | 2 (67) | 7 (58) | 19 (86) | 3 (100) | 3 (50) | 36 (72) |
| 2 | 0 | 0 | 0 | 1 (5) | 0 | 0 | 1 (2) |
| Median time from initial diagnosis, mo (range) | 108.3 (29.4-129.9) | 96.1 (43.1-165.3) | 70.8 (30.5-163.8) | 95.3 (16.0-272.2) | 83.1 (50.7-147.1) | 110.4 (25.7-384.7) | 94.8 (16.0-384.7) |
| MM type at initial diagnosis, n (%) | |||||||
| IgG | 4 (100) | 3 (100) | 6 (50) | 15 (68) | 3 (100) | 5 (83) | 36 (72) |
| IgA | 0 | 0 | 5 (42) | 6 (27) | 0 | 1 (17) | 12 (24) |
| Light chain only | 0 | 0 | 1 (8) | 1 (5) | 0 | 0 | 2 (4) |
| ISS stage at study entry, n (%) | |||||||
| I | 3 (75) | 1 (33) | 5 (42) | 6 (27) | 2 (67) | 1 (17) | 18 (36) |
| II | 0 | 1 (33) | 3 (25) | 10 (45) | 1 (33) | 2 (33) | 17 (34) |
| III | 1 (25) | 0 | 4 (33) | 4 (18) | 0 | 2 (33) | 11 (22) |
| Missing∗ | 0 | 1 (33) | 0 | 2 (10) | 0 | 1 (17) | 4 (8) |
| Median corrected calcium, mmol/L (range) | 2.3 (2.3-2.4) | 2.3 (2.2-2.3) | 2.4 (2.2-2.8) | 2.3 (2.2-2.6) | 2.3 (2.2-2.6) | 2.3 (2.2-2.4) | 2.3 (2.2-2.8) |
| Median hemoglobin, g/L (range) | 125 (106-138) | 118 (104-126) | 124.5 (83-153) | 121 (89-145) | 107 (107-122) | 119 (110-152) | 121 (83-153) |
| Median creatinine clearance, mL/min (range) | 83 (44-116) | 71 (52-77) | 86 (30-134) | 81 (31-143) | 97 (91-117) | 107 (56-144) | 86 (30-144) |
| Creatinine clearance category, n (%) | |||||||
| 30 to <60 mL/min | 1 (25) | 1 (33) | 3 (25) | 6 (27) | 0 | 1 (17) | 12 (24) |
| 60 to <90 mL/min | 1 (25) | 2 (67) | 3 (25) | 8 (36) | 0 | 1 (17) | 15 (30) |
| ≥90 mL/min | 2 (50) | 0 | 6 (50) | 8 (36) | 3 (100) | 4 (67) | 23 (46) |
| Lytic bone lesions, n (%) | n = 3 | n = 3 | n = 11 | n = 21 | n = 3 | n = 6 | N = 47 |
| Yes | 3 (100) | 2 (67) | 7 (64) | 12 (57) | 1 (33) | 2 (33) | 27 (57) |
| No | 0 | 1 (33) | 4 (36) | 8 (38) | 2 (67) | 4 (67) | 19 (40) |
| Indeterminate | 0 | 0 | 0 | 1 (5) | 0 | 0 | 1 (2) |
| Plasmacytomas, n (%) | n = 1 | n = 0 | n = 2 | n = 5 | n = 1 | n = 0 | N = 9 |
| Yes | 0 (9) | 0 | 0 | 1 (20) | 1 (100) | 0 | 2 (22) |
| No | 1 (100) | 0 | 2 (100) | 4 (80) | 0 | 0 | 7 (78) |
| Chromosomal aberrations, n (%) | n = 4 | n = 3 | n = 11 | n = 21 | n = 3 | n = 6 | N = 48 |
| High-risk cytogenetics† | 0 | 1 (33) | 4 (36) | 6 (29) | 1 (33) | 3 (50) | 15 (31) |
| Standard-risk cytogenetics | 4 (100) | 2 (67) | 7 (64) | 15 (71) | 2 (67) | 3 (50) | 33 (69) |
| Median number of prior lines of therapy, (range) | 4.0 (2-7) | 3.0 (3-5) | 3.0 (2-12) | 3.0 (2-16) | 4 (3-4) | 4 (2-5) | 3.5 (2-16) |
| Prior treatment, n (%) | |||||||
| Autologous stem cell transplant | 4 (100) | 3 (100) | 10 (83) | 17 (77) | 3 (100) | 6 (100) | 43 (86) |
| Alkylating agent | 4 (100) | 3 (100) | 12 (100) | 20 (91) | 3 (100) | 6 (100) | 48 (96) |
| Anti-CD38 antibody | 1 (25) | 0 | 3 (25) | 7 (32) | 0 | 0 | 11 (22) |
| IMiD | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| PI | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| Refractory status, n (%)‡ | |||||||
| To anti-CD38 antibody | 0 | 0 | 1 (8) | 5 (23) | 0 | 0 | 6 (12) |
| To either an IMiD or a PI | 4 (100) | 3 (100) | 10 (83) | 22 (100) | 3 (100) | 5 (83) | 47 (94) |
| To both an IMiD and a PI | 3 (75) | 1 (33) | 8 (67) | 17 (77) | 0 | 1 (17) | 30 (60) |
| To last line of therapy | 4 (100) | 2 (67) | 10 (83) | 18 (82) | 3 (100) | 4 (67) | 41 (82) |
| To any line of therapy | 4 (100) | 3 (100) | 10 (83) | 22 (100) | 3 (100) | 5 (83) | 47 (94) |
PomDex was administered in combination with mezagitamab 300 mg (per the product label).
ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System.
Percentages may not add up to 100% because of rounding.
Defined as del [17], t[4:14], and t[14:16] (analyzed locally by fluorescence in situ hybridization or conventional cytogenetics [karyotype], according to local standards).
Defined as a <25% reduction in M-protein (response to stable disease during prior therapy) or PD during treatment or within 60 days after the last dose of prior therapy.