Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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)
Query!
Scientific title
A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Query!
Secondary ID [1]
0
0
CWVT078A12101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM)
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of dose limiting toxicity (DLTs) in Cycle 1
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
28 days (first cycle)
Query!
Primary outcome [2]
0
0
Frequency of dose interruptions
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
Up to 28 months
Query!
Primary outcome [3]
0
0
Frequency of discontinuations
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
up to 28 months
Query!
Primary outcome [4]
0
0
Frequency of dose reductions
Query!
Assessment method [4]
0
0
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
Query!
Timepoint [4]
0
0
up to 28 months
Query!
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
Query!
Assessment method [5]
0
0
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
Query!
Timepoint [5]
0
0
Up to 31 months
Query!
Secondary outcome [1]
0
0
Best Overall Response (BOR)
Query!
Assessment method [1]
0
0
Response assessment per International Myeloma Working Group (IMWG) criteria
Query!
Timepoint [1]
0
0
Up to 36 months
Query!
Secondary outcome [2]
0
0
Duration of Response (DOR)
Query!
Assessment method [2]
0
0
Response assessment per International Myeloma Working Group (IMWG) criteria
Query!
Timepoint [2]
0
0
Up to 36 months
Query!
Secondary outcome [3]
0
0
Progresson Free Survival (PFS)
Query!
Assessment method [3]
0
0
Response assessment per International Myeloma Working Group (IMWG) criteria
Query!
Timepoint [3]
0
0
Up to 36 months
Query!
Secondary outcome [4]
0
0
AUC of WVT078 derived from serum concentrations
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to 28 months
Query!
Secondary outcome [5]
0
0
Cmax of WVT078 derived from serum concentrations
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to 28 months
Query!
Secondary outcome [6]
0
0
Cmin of WVT078 derived from serum concentrations
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 28 months
Query!
Secondary outcome [7]
0
0
Tmax of WVT078 derived from serum concentrations
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 28 months
Query!
Secondary outcome [8]
0
0
T1/2 of WVT078 derived from serum concentrations
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Up to 28 months
Query!
Secondary outcome [9]
0
0
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to 28 months
Query!
Secondary outcome [10]
0
0
AUC of WHG626 derived from plasma concentrations
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to 28 months
Query!
Secondary outcome [11]
0
0
Cmax of WHG626 derived from plasma concentrations
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to 28 months
Query!
Secondary outcome [12]
0
0
Cmin of WHG626 derived from plasma concentrations
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Up to 28 months
Query!
Secondary outcome [13]
0
0
Tmax of WHG626 derived from plasma concentrations
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Up to 28 months
Query!
Secondary outcome [14]
0
0
T1/2 of WHG626 derived from plasma concentrations
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Up to 28 months
Query!
Secondary outcome [15]
0
0
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Up to 28 months
Query!
Secondary outcome [16]
0
0
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Up to 28 months
Query!
Secondary outcome [17]
0
0
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Up to 28 months
Query!
Secondary outcome [18]
0
0
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Up to 28 months
Query!
Secondary outcome [19]
0
0
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
Up to 28 months
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/12/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
2/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
56
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Prahran
Query!
Recruitment postcode(s) [1]
0
0
3181 - Prahran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Wisconsin
Query!
Country [3]
0
0
Germany
Query!
State/province [3]
0
0
Dresden
Query!
Country [4]
0
0
Germany
Query!
State/province [4]
0
0
Heidelberg
Query!
Country [5]
0
0
Israel
Query!
State/province [5]
0
0
Tel Aviv
Query!
Country [6]
0
0
Italy
Query!
State/province [6]
0
0
MI
Query!
Country [7]
0
0
Japan
Query!
State/province [7]
0
0
Tokyo
Query!
Country [8]
0
0
Norway
Query!
State/province [8]
0
0
Oslo
Query!
Country [9]
0
0
Spain
Query!
State/province [9]
0
0
Cantabria
Query!
Country [10]
0
0
Spain
Query!
State/province [10]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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)
Query!
Trial website
https://clinicaltrials.gov/study/NCT04123418
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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