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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/NCT04123418
Registration number
NCT04123418
Ethics application status
Date submitted
2/10/2019
Date registered
10/10/2019
Date last updated
15/03/2024
Titles & IDs
Public title
A Study of WVT078 in Patients With Multiple Myeloma (MM)
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Scientific title
A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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Secondary ID [1]
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CWVT078A12101
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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 (MM)
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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
Other interventions - WVT078
Treatment: Drugs - WHG626
Experimental: WVT078 in Multiple Myeloma (MM) patients - Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
Experimental: WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients - Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
Other interventions: WVT078
WVT078 will be administered IV (intravenously) in a dose escalation schedule
Treatment: Drugs: WHG626
WHG626 will be administered orally in a dose escalation schedule
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Incidence of dose limiting toxicity (DLTs) in Cycle 1
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Assessment method [1]
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To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
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Timepoint [1]
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28 days (first cycle)
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Primary outcome [2]
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Frequency of dose interruptions
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Assessment method [2]
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To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
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Timepoint [2]
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Up to 28 months
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Primary outcome [3]
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Frequency of discontinuations
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Assessment method [3]
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To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
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Timepoint [3]
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up to 28 months
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Primary outcome [4]
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Frequency of dose reductions
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Assessment method [4]
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To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
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Timepoint [4]
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up to 28 months
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Primary outcome [5]
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Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions
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Assessment method [5]
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To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
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Timepoint [5]
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Up to 31 months
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Secondary outcome [1]
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Best Overall Response (BOR)
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Assessment method [1]
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Response assessment per International Myeloma Working Group (IMWG) criteria
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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Response assessment per International Myeloma Working Group (IMWG) criteria
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Progresson Free Survival (PFS)
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Assessment method [3]
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Response assessment per International Myeloma Working Group (IMWG) criteria
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Timepoint [3]
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Up to 36 months
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Secondary outcome [4]
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AUC of WVT078 derived from serum concentrations
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Assessment method [4]
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Timepoint [4]
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Up to 28 months
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Secondary outcome [5]
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Cmax of WVT078 derived from serum concentrations
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Assessment method [5]
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Timepoint [5]
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Up to 28 months
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Secondary outcome [6]
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Cmin of WVT078 derived from serum concentrations
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Assessment method [6]
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Timepoint [6]
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Up to 28 months
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Secondary outcome [7]
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Tmax of WVT078 derived from serum concentrations
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Assessment method [7]
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Timepoint [7]
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Up to 28 months
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Secondary outcome [8]
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T1/2 of WVT078 derived from serum concentrations
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Assessment method [8]
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Timepoint [8]
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Up to 28 months
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Secondary outcome [9]
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Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
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Assessment method [9]
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Timepoint [9]
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Up to 28 months
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Secondary outcome [10]
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AUC of WHG626 derived from plasma concentrations
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Assessment method [10]
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Timepoint [10]
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Up to 28 months
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Secondary outcome [11]
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Cmax of WHG626 derived from plasma concentrations
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Assessment method [11]
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Timepoint [11]
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Up to 28 months
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Secondary outcome [12]
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Cmin of WHG626 derived from plasma concentrations
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Assessment method [12]
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Timepoint [12]
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Up to 28 months
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Secondary outcome [13]
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Tmax of WHG626 derived from plasma concentrations
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Assessment method [13]
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Timepoint [13]
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Up to 28 months
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Secondary outcome [14]
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T1/2 of WHG626 derived from plasma concentrations
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Assessment method [14]
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Timepoint [14]
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Up to 28 months
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Secondary outcome [15]
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AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
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Assessment method [15]
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Timepoint [15]
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Up to 28 months
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Secondary outcome [16]
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Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
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Assessment method [16]
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Timepoint [16]
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Up to 28 months
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Secondary outcome [17]
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Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
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Assessment method [17]
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Timepoint [17]
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Up to 28 months
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Secondary outcome [18]
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Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
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Assessment method [18]
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Timepoint [18]
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Up to 28 months
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Secondary outcome [19]
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T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
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Assessment method [19]
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Timepoint [19]
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Up to 28 months
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Eligibility
Key inclusion criteria
- Subjects who are relapsed and/or refractory to two or more regimens including an IMID,
proteasome inhibitor, and an anti-CD38 agent (if available)
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Minimum age
18
Years
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Maximum age
99
Years
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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
- Use of systemic chronic steroid therapy (>or= 10mg/day prednisone or equivalent) or
any immunosuppressive therapy within 7 days of first dose of study treatment
- Malignant disease other than being treated on this study
- Active known or suspected autoimmune disease
- Impaired cardiac function or clinically significant cardiac disease
- Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy
within 14 days or 5 half-lives whichever is shorter
- Active central nervous system involvement by malignancy or presence of symptomatic CNS
metasteses
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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
Active, not 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
5/12/2019
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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
2/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
56
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Prahran
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Recruitment postcode(s) [1]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Wisconsin
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Country [3]
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Germany
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State/province [3]
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Dresden
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Country [4]
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Germany
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State/province [4]
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Heidelberg
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Country [5]
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Israel
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State/province [5]
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Tel Aviv
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Country [6]
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Italy
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State/province [6]
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MI
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Country [7]
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Japan
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State/province [7]
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Tokyo
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Country [8]
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Norway
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State/province [8]
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Oslo
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Country [9]
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Spain
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State/province [9]
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Cantabria
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Country [10]
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Spain
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State/province [10]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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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
The design of a phase I, open-label, dose finding study was chosen in order to establish a
safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in
patients relapses and/or refractory Multiple Myeloma (MM)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04123418
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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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Address
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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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Address
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04123418
Download to PDF