search
Back to results

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

Primary Purpose

Multiple Myeloma (MM)

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
WVT078
WHG626
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma (MM) focused on measuring Multiple Myeloma, phase 1

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University School of Medicine
  • University of Wisconsin
  • Medical College of Wisconsin
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

WVT078 in Multiple Myeloma (MM) patients

WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients

Arm Description

Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)

Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicity (DLTs) in Cycle 1
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
Frequency of dose interruptions
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
Frequency of discontinuations
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
Frequency of dose reductions
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
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions
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

Secondary Outcome Measures

Best Overall Response (BOR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Duration of Response (DOR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Progresson Free Survival (PFS)
Response assessment per International Myeloma Working Group (IMWG) criteria
AUC of WVT078 derived from serum concentrations
Cmax of WVT078 derived from serum concentrations
Cmin of WVT078 derived from serum concentrations
Tmax of WVT078 derived from serum concentrations
T1/2 of WVT078 derived from serum concentrations
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
AUC of WHG626 derived from plasma concentrations
Cmax of WHG626 derived from plasma concentrations
Cmin of WHG626 derived from plasma concentrations
Tmax of WHG626 derived from plasma concentrations
T1/2 of WHG626 derived from plasma concentrations
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations

Full Information

First Posted
October 2, 2019
Last Updated
August 1, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04123418
Brief Title
A Study of WVT078 in Patients With Multiple Myeloma (MM)
Official Title
A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma (MM)
Keywords
Multiple Myeloma, phase 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WVT078 in Multiple Myeloma (MM) patients
Arm Type
Experimental
Arm Description
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
Arm Title
WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients
Arm Type
Experimental
Arm Description
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
Intervention Type
Biological
Intervention Name(s)
WVT078
Intervention Description
WVT078 will be administered IV (intravenously) in a dose escalation schedule
Intervention Type
Drug
Intervention Name(s)
WHG626
Intervention Description
WHG626 will be administered orally in a dose escalation schedule
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicity (DLTs) in Cycle 1
Description
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
Time Frame
28 days (first cycle)
Title
Frequency of dose interruptions
Description
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
Time Frame
Up to 28 months
Title
Frequency of discontinuations
Description
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
Time Frame
up to 28 months
Title
Frequency of dose reductions
Description
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
Time Frame
up to 28 months
Title
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions
Description
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
Time Frame
Up to 31 months
Secondary Outcome Measure Information:
Title
Best Overall Response (BOR)
Description
Response assessment per International Myeloma Working Group (IMWG) criteria
Time Frame
Up to 36 months
Title
Duration of Response (DOR)
Description
Response assessment per International Myeloma Working Group (IMWG) criteria
Time Frame
Up to 36 months
Title
Progresson Free Survival (PFS)
Description
Response assessment per International Myeloma Working Group (IMWG) criteria
Time Frame
Up to 36 months
Title
AUC of WVT078 derived from serum concentrations
Time Frame
Up to 28 months
Title
Cmax of WVT078 derived from serum concentrations
Time Frame
Up to 28 months
Title
Cmin of WVT078 derived from serum concentrations
Time Frame
Up to 28 months
Title
Tmax of WVT078 derived from serum concentrations
Time Frame
Up to 28 months
Title
T1/2 of WVT078 derived from serum concentrations
Time Frame
Up to 28 months
Title
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Time Frame
Up to 28 months
Title
AUC of WHG626 derived from plasma concentrations
Time Frame
Up to 28 months
Title
Cmax of WHG626 derived from plasma concentrations
Time Frame
Up to 28 months
Title
Cmin of WHG626 derived from plasma concentrations
Time Frame
Up to 28 months
Title
Tmax of WHG626 derived from plasma concentrations
Time Frame
Up to 28 months
Title
T1/2 of WHG626 derived from plasma concentrations
Time Frame
Up to 28 months
Title
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame
Up to 28 months
Title
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame
Up to 28 months
Title
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Time Frame
Up to 28 months
Title
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame
Up to 28 months
Title
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame
Up to 28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novartis Investigative Site
City
Bunkyo ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Facility Name
Novartis Investigative Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs