Trial · NCT04892446
Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma
NCT04892446, Phase 2, Terminated, Gilead Sciences; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma. Trials, record NCT04892446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04892446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT04892446
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Multiple Myeloma
- Interventions
- Magrolimab, Daratumumab, Pomalidomide, Dexamethasone, Bortezomib, Carfilzomib
- First posted
- 2021-05-19
- Last updated
- 2025-05-02
- Other registries' IDs
- eudract:2021-001798-21
- Results first posted
- 2025-05-02
- Limitations and caveats
This study was terminated early due to the Sponsor's decision to discontinue development of the investigational drug and program closure. Due to early termination of the study, reported findings should be interpreted in the context of the study's early closure.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 35 days | A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity, that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the adverse event (AE) was at least possibly related to magrolimab. Percentages are rounded off. |
| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 | Up to 1.3 years plus 70 days | An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. A treatment-emergent AE was defined as any AE that began on or after the date of first dose of any study drug up to the date of last dose of any study drug plus 70 days. |
| Primary | Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Up to 1.3 years plus 70 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and included the date of last dose of study drug plus 70 days for participants who permanently discontinued study drug, or the day before initiation of new anticancer therapy including stem cell transplant (SCT) (whichever was earlier). If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Percentages are rounded off. |
| Primary | Objective Response Rate (ORR) | Up to 1.5 years | Objective response rate is defined as the percentage of participants who achieve confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator per the International Myeloma Working Group (IMWG) 2016 criteria. CR defined as negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow (BM) aspirates; sCR defined as CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in BM biopsy by immunohistochemistry; VGPR defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 h; PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. Percentages are rounded off. |
| Secondary | Duration of Response (DoR) | Up to 1.5 years | DoR was measured from earliest date of sCR, CR, VGPR, or PR, whichever was first recorded, until earliest date of documented progression disease (PD) per IMWG 2016, documented relapse, or death from any cause, whichever occurred first. sCR, CR, VGPR, or PR are defined in outcome measure #4. PD is having any 1 or more of following criteria: increase of 25% from lowest confirmed response value; increase between involved and uninvolved FLC levels \>10 mg/dL; increase in BM plasma-cell ≥10%; appearance of new lesion, ≥ 50% increase in sum of products of 2 longest perpendicular diameters of \>1 lesion, or ≥ 50% increase in longest diameter of a previous lesion \>1 cm in short axis; ≥ 50% increase in circulating plasma cells. Relapse is new soft tissue plasmacytomas or bone lesions; increase in size of existing plasmacytomas or bone lesions; hypercalcemia (\> 11 mg/dL); decrease in hemoglobin of ≥ 2 g/dL; rise in serum creatinine by 2 mg/dL; hyperviscosity. Kaplan Meier estimates were used. |
| Secondary | Serum Concentration of Magrolimab | Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13 | Arm 1: Magrolimab+Daratumumab; Arm 2: Magrolimab+Pomalidomide+Dexamethasone; Arm 3: Magrolimab+Carfilzomib+Dexamethasone. |
| Secondary | Percentage of Participants With Positive Anti-magrolimab Antibodies | Up to Day 358 | The percentage of participants who had treatment induced or treatment-boosted anti-drug antibody (ADA) based on participants who had non-missing baseline ADA sample and at least one post-treatment ADA result reported in Immunogenicity Analysis Set. Treatment-Induced ADA: participants who had negative baseline ADA sample and at least one positive post-treatment ADA sample based on participants who had both non-missing baseline and at least one post-treatment ADA result reported. Treatment-Boosted ADA: participants who had positive baseline ADA sample and at least one positive post-treatment ADA sample and the (max titer of the posttreatment ADA) / (titer of baseline ADA) \>= 4. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 35 days | The DLT-Evaluable Analysis Set included all participants in the Safety Analysis Set who were enrolled in the Safety Run-in cohorts and fulfilled the criteria for evaluation for DLT specified in the protocol. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 | Up to 1.3 years plus 70 days | The Safety Analysis Set included all participants who received at least 1 dose of study treatment with treatment group designated according to the actual treatment received.~As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Up to 1.3 years plus 70 days | Participants in the Safety Analysis Set were analyzed. As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate (ORR) | Up to 1.5 years | The Full Analysis Set included all participants who took ≥ 1 dose of study drugs with arm designated according to the planned treatment at enrollment.~As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Up to 1.5 years | Participants in the Full Analysis Set who had objective response were analyzed. Participants who were observed to have documented relapse, documented PD, or death were censored at the date of their last response assessment.~As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | months | MEDIAN |
| SECONDARY | Serum Concentration of Magrolimab | Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13 | The Pharmacokinetic Analysis Set included all participants who received ≥ 1 dose of magrolimab and had ≥ 1 measurable posttreatment serum concentration of magrolimab. Participants with available data were analyzed.~As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants With Positive Anti-magrolimab Antibodies | Up to Day 358 | The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.~As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Magrolimab+Daratumumab | 16.7 | percentage of participants | ||
| Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Magrolimab+Pomalidomide+Dexamethasone | 16.7 | percentage of participants | ||
| Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Magrolimab+Carfilzomib+Dexamethasone | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 | Magrolimab+Daratumumab | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 | Magrolimab+Pomalidomide+Dexamethasone | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 | Magrolimab+Carfilzomib+Dexamethasone | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Magrolimab+Daratumumab | Hematology: Any Grade 1 or Higher | 92.9 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Magrolimab+Pomalidomide+Dexamethasone | Hematology: Any Grade 1 or Higher | 100 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Magrolimab+Carfilzomib+Dexamethasone | Hematology: Any Grade 1 or Higher | 100 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 | Magrolimab+Daratumumab | Chemistry: Any Grade 1 or Higher | 92.9 | percentage of participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Magrolimab+Daratumumab | 15 | |
| Overall Study | STARTED | Magrolimab+Pomalidomide+Dexamethasone | 10 | |
| Overall Study | STARTED | Magrolimab+Carfilzomib+Dexamethasone | 11 | |
| Overall Study | COMPLETED | Magrolimab+Daratumumab | 7 | |
| Overall Study | COMPLETED | Magrolimab+Pomalidomide+Dexamethasone | 5 | |
| Overall Study | COMPLETED | Magrolimab+Carfilzomib+Dexamethasone | 8 | |
| Overall Study | NOT COMPLETED | Magrolimab+Daratumumab | 8 | |
| Overall Study | NOT COMPLETED | Magrolimab+Pomalidomide+Dexamethasone | 5 | |
| Overall Study | NOT COMPLETED | Magrolimab+Carfilzomib+Dexamethasone | 3 |
Source ClinicalTrials.gov
Adverse events441
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Magrolimab+Daratumumab | 7 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Magrolimab+Pomalidomide+Dexamethasone | 6 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Magrolimab+Carfilzomib+Dexamethasone | 6 | 11 | |
| other | Haemolysis | Blood and lymphatic system disorders | Magrolimab+Daratumumab | 0 | 14 | |
| other | Haemolysis | Blood and lymphatic system disorders | Magrolimab+Pomalidomide+Dexamethasone | 0 | 10 | |
| other | Haemolysis | Blood and lymphatic system disorders | Magrolimab+Carfilzomib+Dexamethasone | 1 | 11 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab+Daratumumab | 0 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab+Pomalidomide+Dexamethasone | 2 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab+Carfilzomib+Dexamethasone | 1 | 11 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Magrolimab+Daratumumab | 2 | 14 |
1 to 10 of 441Source ClinicalTrials.gov
See all 441 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Magrolimab+Daratumumab | 4 | 15 |
| Total, all-cause mortality | Magrolimab+Pomalidomide+Dexamethasone | 4 | 10 |
| Total, all-cause mortality | Magrolimab+Carfilzomib+Dexamethasone | 0 | 11 |
| Total, other adverse events | Magrolimab+Daratumumab | 14 | 14 |
| Total, other adverse events | Magrolimab+Pomalidomide+Dexamethasone | 10 | 10 |
| Total, other adverse events | Magrolimab+Carfilzomib+Dexamethasone | 11 | 11 |
| Total, serious adverse events | Magrolimab+Daratumumab | 5 | 14 |
| Total, serious adverse events | Magrolimab+Pomalidomide+Dexamethasone | 5 | 10 |
| Total, serious adverse events | Magrolimab+Carfilzomib+Dexamethasone | 4 | 11 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04892446
GET https://conductscience.org/api/trials/v1/NCT04892446/results?page=2