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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05243342
Registration number
NCT05243342
Ethics application status
Date submitted
1/02/2022
Date registered
17/02/2022
Date last updated
6/05/2024
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
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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
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Secondary ID [1]
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GO43073
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants with adverse events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [1]
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Serum concentration of XmAb24306
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Assessment method [1]
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Timepoint [1]
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Baseline to approximately 3 years
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Secondary outcome [2]
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Objective response rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Baseline to approximately 3 years
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Secondary outcome [3]
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Prevalence of XmAb24306 anti-drug antibodies (ADAs)
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Assessment method [3]
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Timepoint [3]
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Baseline to approximately 3 years
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Secondary outcome [4]
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Incidence of XmAb24306 ADAs
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Assessment method [4]
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Timepoint [4]
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Baseline to approximately 3 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Alfred Hospital - Melbourne
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Recruitment hospital [3]
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The Perth Blood Institute - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Odense C
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Country [2]
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Denmark
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State/province [2]
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Vejle
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Country [3]
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Norway
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State/province [3]
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Oslo
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Country [4]
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Spain
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State/province [4]
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Barcelona
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Country [5]
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Spain
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State/province [5]
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Salamanca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genentech, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of
XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable
of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or
refractory (R/R) MM who have received a minimum of three prior treatments, including at least
one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal
antibody.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05243342
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: GO43073 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05243342
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