Trial · NCT06055075

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

NCT06055075, Phase 1, Phase 2, Terminated, Hoffmann-La Roche

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma. Trials, record NCT06055075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06055075

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
NCT number: NCT06055075
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 21 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Relapsed or Refractory Multiple Myeloma
Interventions: Forimtamig, Carfilzomib, Daratumumab
First posted: 2023-09-26
Last updated: 2026-09-29

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Effects (AEs)	From initiation of study treatment up to approximately 15.7 months	AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Primary	Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading	From initiation of study treatment up to approximately 15.7 months	CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, headache, and myalgia and may also include hypotension, capillary leak (hypoxia), dyspnea, chest discomfort and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Primary	Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading	From initiation of study treatment up to approximately 15.7 months	ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging.
Primary	Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria	Up to approximately 15.2 months	ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas.
Primary	Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria	Up to approximately 15.2 months	CRR and sCRR were defined as the percentage of participants with CR or sCR, as determined by the investigator per IMWG response criteria. CR was defined as: no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum \& urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells in BM \& a normal SFLC ratio of 0.26-1.65. sCR was defined as: CR (defined above); normal SFLC ratio, \& absence of clonal cells in BM by IHC or negative by 2-4 color flow cytometry. CR and sCR are distinct response categories and are evaluated and reported separately in accordance with the defined response criteria i.e., if a response is clinically upgraded from CR to sCR it is not further considered a CR but solely a sCR. Percentages have been rounded off.
Primary	Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria	Up to approximately 15.2 months	VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off.
Secondary	Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria	Up to approximately 15.2 months	PFS=time from randomization until disease progression (PD) per IMWG criteria or death from any cause. PD=any 1 or more of the following: Increase of 25% from lowest response value in any of the following: Serum M-component, Urine M-component or in participants without measurable SMP \& UMP levels: difference between involved \& uninvolved FLC levels; For non-secretory participants at study entry: in participants without measurable SMP \& UMP levels \& without measurable disease by FLC: BM plasma cell percentage irrespective of baseline status (absolute %must be ≥10%); appearance of a new lesion/s, ≥ 50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1centimeters (cm) in short axis; Definite development of new bone lesions/definite increase in the size of existing bone lesions; ≥50% increase in circulating plasma cells. Kaplan-Meier (K-M) method was used to estimate the median PFS. Overall number analyzed=participants with an event.
Secondary	Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better	Up to approximately 15.2 months	DoR was defined as the time from the initial objective response (OR) (sCR, CR, PR, or VGPR) to the time of PD or death from any cause as determined by the investigator per IMWG response criteria. CR, sCR, VGPR, and PR were defined the same as outlined in the description for the primary endpoint ORR. PD was defined as outlined in the description for the endpoint PFS. K-M method was used to estimate the median DOR.
Secondary	Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria	Up to approximately 15.2 months	TTR was defined as the time from randomization until an OR (PR or better), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTR.
Secondary	Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria	Up to approximately 15.2 months	TTBR was defined as the time from randomization until the best OR (sCR, CR, VGPR, or PR), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTBR.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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