A Study of WVT078 in Patients With Multiple Myeloma (MM)

A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma

ClinicalTrials.gov Identifier: NCT04123418

Novartis Reference Number: CWVT078A12101

Last Update: Nov 20, 2020

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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)

Condition 
Multiple Myeloma (MM)
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
90 participants
Start date 
Dec 05, 2019
Completion date 
Apr 21, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
WVT078
WVT078 will be administered IV (intravenously) in a dose escalation schedule
Drug
WHG626
WHG626 will be administered orally in a dose escalation schedule

Eligibility Criteria

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)

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 Locations

United States
Emory University School of Medicine
Recruiting
Atlanta, 30322
Georgia
United States
Medical College of Wisconsin
Recruiting
Milwaukee, 53226
Wisconsin
United States
Australia
Novartis Investigative Site
Recruiting
Prahran, 3181
Victoria
Australia
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Israel
Novartis Investigative Site
Recruiting
Tel Aviv, 6423906
-
Israel
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8677
Tokyo
Japan
Norway
Novartis Investigative Site
Recruiting
Oslo, NO 0450
-
Norway
Spain
Novartis Investigative Site
Recruiting
Santander, 39008
Cantabria
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]