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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06055075




Registration number
NCT06055075
Ethics application status
Date submitted
20/09/2023
Date registered
26/09/2023

Titles & IDs
Public title
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
2023-503689-21-00
Secondary ID [2] 0 0
BP43437
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Forimtamig
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Daratumumab

Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib - Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib - Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib - Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab - Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab - Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab - Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Expansion Phase: Forimtamig - 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.

Experimental: Dose Expansion Phase: Forimtamig + Carfilzomib - Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Expansion Phase: Forimtamig + Daratumumab - Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.


Treatment: Drugs: Forimtamig
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.

Treatment: Drugs: Carfilzomib
Carfilzomib will be administered via IV infusion in combination with forimtamig.

Treatment: Drugs: Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 24 months
Primary outcome [2] 0 0
Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
Timepoint [2] 0 0
Up to approximately 24 months
Primary outcome [3] 0 0
Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
Timepoint [3] 0 0
Up to approximately 24 months
Primary outcome [4] 0 0
Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria
Timepoint [2] 0 0
Up to approximately 24 months
Secondary outcome [3] 0 0
Time to First Response as Determined by the Investigator per IMWG Criteria
Timepoint [3] 0 0
Up to approximately 24 months
Secondary outcome [4] 0 0
Time to Best Response as Determined by the Investigator per IMWG Criteria
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [5] 0 0
Overall Survival (OS) as Determined by the Investigator per IMWG Criteria
Timepoint [5] 0 0
Up to approximately 24 months
Secondary outcome [6] 0 0
Serum Concentration of Forimtamig
Timepoint [6] 0 0
Up to approximately 24 months
Secondary outcome [7] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
Timepoint [7] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/06/2027
Actual
Sample size
Target
316
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Brazil
State/province [3] 0 0
RJ
Country [4] 0 0
Brazil
State/province [4] 0 0
SP
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus N
Country [7] 0 0
Denmark
State/province [7] 0 0
København Ø
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense C
Country [9] 0 0
France
State/province [9] 0 0
Lille
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
Germany
State/province [11] 0 0
Augsburg
Country [12] 0 0
Germany
State/province [12] 0 0
Leipzig
Country [13] 0 0
Germany
State/province [13] 0 0
Nürnberg
Country [14] 0 0
Italy
State/province [14] 0 0
Campania
Country [15] 0 0
Italy
State/province [15] 0 0
Emilia-Romagna
Country [16] 0 0
Italy
State/province [16] 0 0
Lombardia
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
Spain
State/province [19] 0 0
Cantabria
Country [20] 0 0
Spain
State/province [20] 0 0
Navarra
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP43437 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06055075