Relapsed or Refractory Multiple MyelomaPhase 1/2NCT06055075
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing Forimtamig, Carfilzomib and Daratumumab in people with Relapsed or Refractory Multiple Myeloma, run by Hoffmann-La Roche at 8 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Forimtamig, Carfilzomib and Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 8 Dec 2023to 8 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Documented diagnosis of MM according to the IMWG diagnostic criteria
- Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
- Measurable disease
- AEs from prior anti-cancer therapy resolved to Grade ≤ 1,
- Adequate organ functions
Who cannot join
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
- Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL)
- Participants with known amyloidosis
- Participants with myelodysplastic syndrome
- Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
- Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration
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- Prior solid organ transplantation
- Active auto-immune disease or flare within 6 months prior to start of study treatment
- Known or suspected chronic active Epstein-Barr virus (EBV) infection
- Hepatitis B virus (HBV) infection
- Acute or chronic hepatitis C virus (HCV) infection
- Known history of HIV seropositivity
- Live vaccine(s) within one month prior to start of the treatment
- Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations
- Previous refractoriness to carfilzomib
- Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity
- Participants with known liver cirrhosis
- Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, 4102
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Seoul St Mary's Hospital
Seoul, 06591
About this study
Official title: An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Forimtamig, Carfilzomib, Daratumumab
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForimtamigDrug
Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.
CarfilzomibDrug
Carfilzomib will be administered via IV infusion in combination with forimtamig.
DaratumumabDrug
Daratumumab will be administered via SC injection in combination with forimtamig.
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib | Experimental | Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression. Receives: Drug: Forimtamig; Drug: Carfilzomib |
| Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib | Experimental | Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. Receives: Drug: Forimtamig; Drug: Carfilzomib |
| Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib | Experimental | Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. Receives: Drug: Forimtamig; Drug: Carfilzomib |
| Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab | Experimental | Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. Receives: Drug: Forimtamig; Drug: Daratumumab |
| Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab | Experimental | Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. Receives: Drug: Forimtamig; Drug: Daratumumab |
| Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab | Experimental | Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. Receives: Drug: Forimtamig; Drug: Daratumumab |
| Dose Expansion Phase: Forimtamig | Experimental | Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first. Receives: Drug: Forimtamig |
| Dose Expansion Phase: Forimtamig + Carfilzomib | Experimental | Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression. Receives: Drug: Forimtamig; Drug: Carfilzomib |
| Dose Expansion Phase: Forimtamig + Daratumumab | Experimental | Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression. Receives: Drug: Forimtamig; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Effects (AEs)
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.
Measured: From initiation of study treatment up to approximately 15.7 months
Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading
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.
Measured: From initiation of study treatment up to approximately 15.7 months
Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading
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.
Measured: From initiation of study treatment up to approximately 15.7 months
Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria
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.
Measured: Up to approximately 15.2 months
Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria
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.
Measured: Up to approximately 15.2 months
Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria
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.
Measured: Up to approximately 15.2 months
Secondary outcomes (9)
Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria
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.
Measured: Up to approximately 15.2 months
Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better
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.
Measured: Up to approximately 15.2 months
Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria
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.
Measured: Up to approximately 15.2 months
Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria
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.
Measured: Up to approximately 15.2 months
Investigator-assessed Overall Survival (OS)
OS was defined as the time from randomization to death from any cause as determined by the investigator per IMWG response criteria. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.
Measured: Up to approximately 15.7 months
Number of Participants With Anti-drug Antibodies (ADAs) to Forimtamig
Participants who received forimtamig were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following forimtamig exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Measured: Up to approximately 15.7 months
Serum Concentrations of Forimtamig at the Specified Timepoints
Measured: Pre-dose on Day (D)1 of Cycle (C)1,2&4, D4 of C1&5, D2C3; 4hours post-dose on D1,4 of C1, D2C3, D1C4, D4C5; D2,8,9,11,15,16&18 of C1; D2,8,15,22 of C2&4; D1,4,8,15,22 of C3; D1,8,15 of C5; D1,4,8,15 of C6,7,8&9; D1,4,8 of C10
Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig
Measured: Up to Day 15 of Cycle 3 (1 cycle=28 days)
Maximum Observed Concentration (Cmax) of Forimtamig
Measured: Day 1 of Cycle 3 (1 cycle=28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start8 Dec 2023
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Why it stopped: The study was terminated prematurely because the Sponsor decided not to pursue the development of forimtamig.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055075
- Sponsor's protocol ID
- BP43437
- Other IDs
- 2023-503689-21-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2023
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06055075
- Acronym / sponsor ID
- BP43437
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because the Sponsor decided not to pursue the development of forimtamig.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib | Experimental | Drug: Forimtamig, Drug: CarfilzomibParticipants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib | Experimental | Drug: Forimtamig, Drug: CarfilzomibParticipants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib | Experimental | Drug: Forimtamig, Drug: CarfilzomibParticipants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab | Experimental | Drug: Forimtamig, Drug: DaratumumabParticipants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab | Experimental | Drug: Forimtamig, Drug: DaratumumabParticipants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab | Experimental | Drug: Forimtamig, Drug: DaratumumabParticipants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Expansion Phase: Forimtamig | Experimental | Drug: ForimtamigParticipants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first. |
| Dose Expansion Phase: Forimtamig + Carfilzomib | Experimental | Drug: Forimtamig, Drug: CarfilzomibParticipants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression. |
| Dose Expansion Phase: Forimtamig + Daratumumab | Experimental | Drug: Forimtamig, Drug: DaratumumabParticipants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Documented diagnosis of MM according to the IMWG diagnostic criteria
- Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
- Measurable disease
Key exclusion criteria (18 listed)
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
- Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL)
- Participants with known amyloidosis
- Participants with myelodysplastic syndrome
- Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForimtamigForimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase. | Drug | Dose Expansion Phase: Forimtamig, Dose Expansion Phase: Forimtamig + Carfilzomib, Dose Expansion Phase: Forimtamig + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab |
| CarfilzomibCarfilzomib will be administered via IV infusion in combination with forimtamig. | Drug | Dose Expansion Phase: Forimtamig + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib, Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib |
| DaratumumabDaratumumab will be administered via SC injection in combination with forimtamig. | Drug | Dose Expansion Phase: Forimtamig + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab, Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab |
Primary outcome
Number of Participants With Adverse Effects (AEs)
Time frame: 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.
Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading
Time frame: 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.
Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading
Time frame: 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.
Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria
Time frame: 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.
Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria
Time frame: 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.
Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria
Time frame: 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.
9 secondary outcomes
Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria
Time frame: Up to approximately 15.2 months
Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better
Time frame: Up to approximately 15.2 months
Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria
Time frame: Up to approximately 15.2 months
Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria
Time frame: Up to approximately 15.2 months
Investigator-assessed Overall Survival (OS)
Time frame: Up to approximately 15.7 months
Number of Participants With Anti-drug Antibodies (ADAs) to Forimtamig
Time frame: Up to approximately 15.7 months
Serum Concentrations of Forimtamig at the Specified Timepoints
Time frame: Pre-dose on Day (D)1 of Cycle (C)1,2&4, D4 of C1&5, D2C3; 4hours post-dose on D1,4 of C1, D2C3, D1C4, D4C5; D2,8,9,11,15,16&18 of C1; D2,8,15,22 of C2&4; D1,4,8,15,22 of C3; D1,8,15 of C5; D1,4,8,15 of C6,7,8&9; D1,4,8 of C10
Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig
Time frame: Up to Day 15 of Cycle 3 (1 cycle=28 days)
Maximum Observed Concentration (Cmax) of Forimtamig
Time frame: Day 1 of Cycle 3 (1 cycle=28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Forimtamig, Carfilzomib and Daratumumab in people with Relapsed or Refractory Multiple Myeloma, run by Hoffmann-La Roche at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, South Korea, Canada, Italy, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Effects (AEs) (time frame: From initiation of study treatment up to approximately 15.7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.