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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04123418
Ethics application status
Date submitted
2/10/2019
Date registered
10/10/2019

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
Treatment: Other - 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)


Treatment: Other: 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
Treatment: Other
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
Timepoint [1] 0 0
28 days (first cycle)
Primary outcome [2] 0 0
Frequency of dose interruptions
Timepoint [2] 0 0
Up to 28 months
Primary outcome [3] 0 0
Frequency of discontinuations
Timepoint [3] 0 0
up to 28 months
Primary outcome [4] 0 0
Frequency of dose reductions
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
Timepoint [5] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Best Overall Response (BOR)
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Progresson Free Survival (PFS)
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
99 Years
Sex
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
Accrual to date
Final
56
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
Italy
State/province [6] 0 0
MI
Country [7] 0 0
Japan
State/province [7] 0 0
Tokyo
Country [8] 0 0
Norway
State/province [8] 0 0
Oslo
Country [9] 0 0
Spain
State/province [9] 0 0
Cantabria
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04123418