NCT03450057 · OUTCOME
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment · Source last updated 2024-03-29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).
What was measured
The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.
Groups in this outcome
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 38 |
|---|
Reported measurements
Any (N)SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Any NSAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
Any SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Any (N)SADR related to daratumumab
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Any NSADR related to daratumumab
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Any SADR related to daratumumab
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Any (N)SAE of Grade >=3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Any (N)SAE of Grade 3 or 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Any fatal SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Any (N)SAE
- title
- Any NSAE
- title
- Any SAE
- title
- Any (N)SADR related to daratumumab
- title
- Any NSADR related to daratumumab
- title
- Any SADR related to daratumumab
- title
- Any (N)SAE of Grade >=3
- title
- Any (N)SAE of Grade 3 or 4
- title
- Any fatal SAE
- description
- The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.
- groups
- description
- Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).
- title
- To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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