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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04123418




Registration number
NCT04123418
Ethics application status
Date submitted
2/10/2019
Date registered
10/10/2019
Date last updated
20/11/2020

Titles & IDs
Public title
A Study of WVT078 in Patients With Multiple Myeloma (MM)
Scientific title
A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Secondary ID [1] 0 0
CWVT078A12101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicity (DLTs) in Cycle 1 - 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
Timepoint [1] 0 0
28 days (first cycle)
Primary outcome [2] 0 0
Frequency of dose interruptions - 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
Timepoint [2] 0 0
Up to 28 months
Primary outcome [3] 0 0
Frequency of discontinuations - 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
Timepoint [3] 0 0
up to 28 months
Primary outcome [4] 0 0
Frequency of dose reductions - 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
Timepoint [4] 0 0
up to 28 months
Primary outcome [5] 0 0
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions - 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
Timepoint [5] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Best Overall Response (BOR) - Response assessment per International Myeloma Working Group (IMWG) criteria
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Duration of Response (DOR) - Response assessment per International Myeloma Working Group (IMWG) criteria
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Progresson Free Survival (PFS) - Response assessment per International Myeloma Working Group (IMWG) criteria
Timepoint [3] 0 0
Up to 36 months
Secondary outcome [4] 0 0
AUC of WVT078 derived from serum concentrations
Timepoint [4] 0 0
Up to 28 months
Secondary outcome [5] 0 0
Cmax of WVT078 derived from serum concentrations
Timepoint [5] 0 0
Up to 28 months
Secondary outcome [6] 0 0
Cmin of WVT078 derived from serum concentrations
Timepoint [6] 0 0
Up to 28 months
Secondary outcome [7] 0 0
Tmax of WVT078 derived from serum concentrations
Timepoint [7] 0 0
Up to 28 months
Secondary outcome [8] 0 0
T1/2 of WVT078 derived from serum concentrations
Timepoint [8] 0 0
Up to 28 months
Secondary outcome [9] 0 0
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Timepoint [9] 0 0
Up to 28 months
Secondary outcome [10] 0 0
AUC of WHG626 derived from plasma concentrations
Timepoint [10] 0 0
Up to 28 months
Secondary outcome [11] 0 0
Cmax of WHG626 derived from plasma concentrations
Timepoint [11] 0 0
Up to 28 months
Secondary outcome [12] 0 0
Cmin of WHG626 derived from plasma concentrations
Timepoint [12] 0 0
Up to 28 months
Secondary outcome [13] 0 0
Tmax of WHG626 derived from plasma concentrations
Timepoint [13] 0 0
Up to 28 months
Secondary outcome [14] 0 0
T1/2 of WHG626 derived from plasma concentrations
Timepoint [14] 0 0
Up to 28 months
Secondary outcome [15] 0 0
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Timepoint [15] 0 0
Up to 28 months
Secondary outcome [16] 0 0
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Timepoint [16] 0 0
Up to 28 months
Secondary outcome [17] 0 0
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Timepoint [17] 0 0
Up to 28 months
Secondary outcome [18] 0 0
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Timepoint [18] 0 0
Up to 28 months
Secondary outcome [19] 0 0
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Timepoint [19] 0 0
Up to 28 months

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Wisconsin
Country [3] 0 0
Germany
State/province [3] 0 0
Dresden
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Israel
State/province [5] 0 0
Tel Aviv
Country [6] 0 0
Japan
State/province [6] 0 0
Tokyo
Country [7] 0 0
Norway
State/province [7] 0 0
Oslo
Country [8] 0 0
Spain
State/province [8] 0 0
Cantabria

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/show/NCT04123418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04123418