Table 1.
Summary of Study Designs
| Clinical Trial | Phase | Patient Population | Treatment Arm(s) | Serum Sample Collection Schedule | Study Sites |
|---|---|---|---|---|---|
| PAVO Part 2 | 1b | Relapsed or refractory multiple myeloma | DARA SC 1800 mg: once weekly during cycles 1 and 2, every 2 weeks for cycles 3 through 6, and every 4 weeks thereafter until disease progression or unacceptable toxicity; each cycle was 28 days. | Serum samples were collected postinfusion during the first and last weekly dose on day 1 of cycle 1 and day 22 of cycle 2 and on days without a dose on days 2, 3, and 4 of cycle 1 and days 23 and 25 of cycle 2. | Denmark (1 site), France (2 sites), Spain (3 sites), Sweden (1 site), the Netherlands (1 site), and the United States (3 sites). |
| MMY1008 | 1 | Japanese patients with relapsed or refractory multiple myeloma | DARA SC 1800 mg: once weekly during cycles 1 and 2, every 2 weeks for cycles 3 through 6, and every 4 weeks thereafter until disease progression or unacceptable toxicity; each cycle was 28 days. | Serum samples were collected postinfusion during the first and last weekly doses on day 1 of cycle 1 and day 22 of cycle 2 and on days without a dose on days 2, 3, and 4 of cycle 1 and days 23 and 25 of cycle 2. | Japan (4 sites). |
| COLUMBA | 3 | Relapsed or refractory multiple myeloma | DARA SC 1800 mg or DARA IV 16 mg/kg: once weekly during cycles 1 and 2, every 2 weeks for cycles 3 through 6, and every 4 weeks thereafter until disease progression or unacceptable toxicity; each cycle was 28 days. |
Serum samples were collected preinfusion on days 1 and 15 of cycle 1; day 1 of cycles 2, 3, 5, 7, and 12; and 4 and 8 weeks after the last DARA dose for both the DARA IV and DARA SC arms. Serum samples were also collected postinfusion on day 1 of cycles 1 and 3 for the DARA IV arm and postinfusion on day 4 of cycles 1 and 4 for the DARA SC arm. |
Australia (8 sites), Brazil (11 sites), Canada (7 sites), the Czech Republic (7 sites), France (7 sites), Greece (1 site), Israel (7 sites), Italy (8 sites), Japan (16 sites), Poland (9 sites), Russia (13 sites), Spain (12 sites), South Korea (8 sites), Sweden (6 sites), Taiwan (6 sites), Ukraine (10 sites), the United States (2 sites), and the United Kingdom (9 sites). |
| PLEIADES | 2 | Newly diagnosed multiple myeloma or relapsed or refractory multiple myeloma |
D‐VRd: DARA SC 1800 mg every week for cycles 1 through 3 and every 3 weeks thereafter; each cycle was 3 weeks. D‐VMP: DARA SC 1800 mg every week for cycle 1, every 3 weeks for cycles 2 through 9, and every 4 weeks thereafter; each cycle was 6 weeks for cycles 1 through 9. D‐Rd: DARA SC 1800 mg every week for cycles 1 and 2, every 2 weeks for cycles 3 through 6, and every 4 weeks thereafter; each cycle was 4 weeks. |
D‐VRd: serum samples were collected preinfusion on day 1 of cycles 1, 3, and 4 and postinfusion on day 4 of cycles 1 and 4. D‐VMP: serum samples were collected preinfusion on day 1 of cycles 1, 2, 3, 6, and 9 and postinfusion on day 4 of cycles 1 and 2. D‐Rd: serum samples were collected preinfusion on day 1 of cycles 1, 3, 6, 9, and 12 and postinfusion on day 4 of cycles 1 and 3. All arms also had serum samples collected 4 and 8 weeks after the last DARA dose. |
Brazil (3 sites), the Czech Republic (4 sites), the United States (8 sites), France (5 sites), Israel (5 sites), Spain (9 sites), the United Kingdom (6 sites), and Japan (3 sites). |
DARA, daratumumab; SC, subcutaneous; IV, intravenous; D‐VRd, DARA SC plus bortezomib/lenalidomide/dexamethasone; D‐VMP, DARA SC plus bortezomib/melphalan/prednisone; D‐Rd, DARA SC plus lenalidomide/dexamethasone.