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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05243342




Registration number
NCT05243342
Ethics application status
Date submitted
1/02/2022
Date registered
17/02/2022

Titles & IDs
Public title
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
GO43073
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - XmAb24306
Treatment: Drugs - Daratumumab

Experimental: Dose escalation - Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)

Experimental: Dose expansion - Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)


Treatment: Drugs: XmAb24306
XmAb24306 will be given via intravenous (IV) infusion

Treatment: Drugs: Daratumumab
Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)
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 3 years
Secondary outcome [1] 0 0
Serum concentration of XmAb24306
Timepoint [1] 0 0
Baseline to approximately 3 years
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Baseline to approximately 3 years
Secondary outcome [3] 0 0
Prevalence of XmAb24306 anti-drug antibodies (ADAs)
Timepoint [3] 0 0
Baseline to approximately 3 years
Secondary outcome [4] 0 0
Incidence of XmAb24306 ADAs
Timepoint [4] 0 0
Baseline to approximately 3 years

Eligibility
Key inclusion criteria
* Life expectancy of at least 12 weeks
* Measurable disease, as defined by the protocol
* Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
* Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
* Prior allogeneic stem cell or solid organ transplantation
* Autologous stem cell transplantation within 100 days prior to initiation of study treatment
* Significant cardiovascular disease
* Known clinically significant liver disease
* Active or history of autoimmune disease or immune deficiency
* Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
* Primary or secondary plasma cell leukemia
* Current CNS involvement by MM
* Other protocol defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2024
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Odense C
Country [2] 0 0
Denmark
State/province [2] 0 0
Vejle
Country [3] 0 0
Norway
State/province [3] 0 0
Oslo
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
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: GO43073 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
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/NCT05243342