| Primary | Progression Free Survival (PFS) | Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000NA(NA to NA)The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.
- OG0014.86(3.38 to NA)The upper confidence limit was not available due to insufficient numbers of participants with events.
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Log Rank | | =0.0032 | | Hazard Ratio (HR) | 0.184 | | | 2-Sided | 95 | 0.052 | 0.650 | | | | | Superiority | | |
|
| Secondary | Overall Response Rate (ORR) | Proportion of patients who achieve a best-confirmed response of stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Number | 95% Confidence Interval | percentage of patients | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Duration of Response (DOR) | Time from the first evidence of confirmed assessment of sCR, CR, VGPR or PR to first confirmed disease progression, or death due to any cause. DOR is defined only for patients with a confirmed PR or better. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Best Response | Proportion of patients with sCR, CR, VGPR, PR, Minimal Response (MR), Stable Disease (SD), PD, or non-evaluable (NE). | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Count of Participants | | Participants | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Clinical Benefit Rate (CBR) | The proportion of patients who achieve a best confirmed response of sCR, CR, VGPR, PR, or MR. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Number | 95% Confidence Interval | percentage of patients | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Duration of Clinical Benefit (DOCB) | Time from first evidence of confirmed assessment of sCR, CR, VGPR, PR, or MR to first confirmed disease progression, or to death due to any cause. DOCB is defined only for patients with a confirmed MR or better. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Time to Response (TTR) | Time from randomization to the date of the first documented confirmed response in a patient who has responded with ≥PR. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Mean | Standard Deviation | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Time to Progression (TTP) | Time from randomization to the date of the first documented confirmed PD | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Time to Next Treatment (TTNT) | Time from randomization to the date of next anti-myeloma treatment or until death. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |
| Secondary | Overall Survival (OS) | Time from randomization to death due to any cause. | Analysis was performed using the Full Analysis Set (FAS). | Posted | | Median | 95% Confidence Interval | months | | From the date of randomization until the end of study (approximately 12 months). | | | | ID | Title | Description |
|---|
| OG000 | Arm A (Melflufen+Dexamethasone+Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting.
- Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle
- Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)
- Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| | OG001 | Arm B (Daratumumab) | Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7 |
| |