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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04123418
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Germany, Israel, Italy, Japan, Norway, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma (MM)
Additional Details

This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.

Arms & Interventions

Arms

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)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emory University School of Medicine, Atlanta, Georgia

Status

Recruiting

Address

Emory University School of Medicine

Atlanta, Georgia, 30322

Site Contact

Sydnea Kanayo Gist

sydnea.gist@emory.edu

+1 404 778 4189

Mayo Clinic Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55905

University of Wisconsin, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin

Madison, Wisconsin, 53792

Site Contact

Samanike Hengst

shengst@wisc.edu

608-262-7202

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Nicholas B Mohrdieck

nmohrdieck@mcw.edu

414-805-5249

International Sites

Novartis Investigative Site, Prahran, Victoria, Australia

Status

Recruiting

Address

Novartis Investigative Site

Prahran, Victoria, 3181

Novartis Investigative Site, Dresden, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dresden, , 01307

Novartis Investigative Site, Heidelberg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Heidelberg, , 69120

Novartis Investigative Site, Tel Aviv, Israel

Status

Recruiting

Address

Novartis Investigative Site

Tel Aviv, , 6423906

Novartis Investigative Site, Milano, MI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milano, MI, 20162

Novartis Investigative Site, Bunkyo ku, Tokyo, Japan

Status

Recruiting

Address

Novartis Investigative Site

Bunkyo ku, Tokyo, 113-8677

Novartis Investigative Site, Oslo, Norway

Status

Recruiting

Address

Novartis Investigative Site

Oslo, , NO 0450

Novartis Investigative Site, Santander, Cantabria, Spain

Status

Recruiting

Address

Novartis Investigative Site

Santander, Cantabria, 39008

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08041