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Unknown

WVT078 + WHG626 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is designed to find a safe and tolerated dose of a new drug for patients with Multiple Myeloma who have relapsed or are refractory to other treatments.

Who is the study for?
This trial is for patients with Multiple Myeloma who have tried at least two treatments, including an IMID, proteasome inhibitor, and anti-CD38 agent if available. It's not for those with other cancers, autoimmune diseases, significant heart issues, recent other cancer treatments or immunosuppressives.Check my eligibility
What is being tested?
The study is testing the safety and appropriate doses of WVT078 alone and combined with WHG626 in people whose Multiple Myeloma has returned or resisted treatment. This early-phase trial will gradually increase doses to find safe levels.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to cancer drugs such as nausea, fatigue, immune system changes, and possible infusion-related reactions due to the newness of these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve after treatments including IMID, proteasome inhibitor, and anti-CD38.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of discontinuations
Frequency of dose interruptions
Frequency of dose reductions
+2 more
Secondary outcome measures
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
AUC of WHG626 derived from plasma concentrations
AUC of WVT078 derived from serum concentrations
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: WVT078 in combination with WHG626 in Multiple Myeloma (MM) patientsExperimental Treatment2 Interventions
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
Group II: WVT078 in Multiple Myeloma (MM) patientsExperimental Treatment1 Intervention
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,294 Total Patients Enrolled
38 Trials studying Multiple Myeloma
2,446 Patients Enrolled for Multiple Myeloma

Media Library

WVT078 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04123418 — Phase 1
Multiple Myeloma Research Study Groups: WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients, WVT078 in Multiple Myeloma (MM) patients
Multiple Myeloma Clinical Trial 2023: WVT078 Highlights & Side Effects. Trial Name: NCT04123418 — Phase 1
WVT078 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04123418 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current openings for enrollees in this clinical trial?

"This investigation, which was posted on December 5th 2019 according to clinicaltrials.gov, is currently seeking participants with the last update being made on October 10th 2022."

Answered by AI

Is the minimum age requirement for this trial 18 years or older?

"Patients aged 18 and up to 99 years old are eligible for participation in this medical trial."

Answered by AI

What is the current scope of participants involved in this experiment?

"Novartis Pharmaceuticals is searching for 90 qualified participants to partake in this trial, which will be conducted at two locations: University of Wisconsin and Medical College of Wisconsin."

Answered by AI

Has the FDA accorded its stamp of approval to WVT078?

"WVT078's safety and efficacy have only been established on a minimal scale, thus it received the lowest score of 1."

Answered by AI

At how many locales is this investigation being monitored?

"Currently, this research study is enrolling out of 4 sites. These locations are Madison, Milwaukee, and Atlanta as well as an additional four spots. For participation in the trial to be most convenient for you, it would behoove you to choose a medical centre closest to your home."

Answered by AI

Who is the ideal candidate for this experimental procedure?

"A cohort of 90 patients, aged between 18 and 99, are needed for this trial. Individuals must have a diagnosis of multiple myeloma and previously been exposed to immunomodulatory drugs (IMIDs), proteasome inhibitors, as well as an anti-CD38 agent if available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of WVT078 in Patients With Multiple Myeloma (MM)
2019. "A Study of WVT078 in Patients With Multiple Myeloma (MM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04123418.
~7 spots leftby Nov 2024
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