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

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123418
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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)

Condition or disease Intervention/treatment Phase
Multiple Myeloma (MM) Biological: WVT078 Drug: WHG626 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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)
Biological: WVT078
WVT078 will be administered IV (intravenously) in a dose escalation schedule

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)
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




Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLTs) in Cycle 1 [ Time Frame: 28 days (first cycle) ]
    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

  2. Frequency of dose interruptions [ Time Frame: Up to 28 months ]
    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

  3. Frequency of discontinuations [ Time Frame: up to 28 months ]
    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

  4. Frequency of dose reductions [ Time Frame: up to 28 months ]
    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

  5. Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions [ Time Frame: Up to 31 months ]
    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 :
  1. Best Overall Response (BOR) [ Time Frame: Up to 36 months ]
    Response assessment per International Myeloma Working Group (IMWG) criteria

  2. Duration of Response (DOR) [ Time Frame: Up to 36 months ]
    Response assessment per International Myeloma Working Group (IMWG) criteria

  3. Progresson Free Survival (PFS) [ Time Frame: Up to 36 months ]
    Response assessment per International Myeloma Working Group (IMWG) criteria

  4. AUC of WVT078 derived from serum concentrations [ Time Frame: Up to 28 months ]
  5. Cmax of WVT078 derived from serum concentrations [ Time Frame: Up to 28 months ]
  6. Cmin of WVT078 derived from serum concentrations [ Time Frame: Up to 28 months ]
  7. Tmax of WVT078 derived from serum concentrations [ Time Frame: Up to 28 months ]
  8. T1/2 of WVT078 derived from serum concentrations [ Time Frame: Up to 28 months ]
  9. Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum [ Time Frame: Up to 28 months ]
  10. AUC of WHG626 derived from plasma concentrations [ Time Frame: Up to 28 months ]
  11. Cmax of WHG626 derived from plasma concentrations [ Time Frame: Up to 28 months ]
  12. Cmin of WHG626 derived from plasma concentrations [ Time Frame: Up to 28 months ]
  13. Tmax of WHG626 derived from plasma concentrations [ Time Frame: Up to 28 months ]
  14. T1/2 of WHG626 derived from plasma concentrations [ Time Frame: Up to 28 months ]
  15. AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations [ Time Frame: Up to 28 months ]
  16. Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations [ Time Frame: Up to 28 months ]
  17. Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations [ Time Frame: Up to 28 months ]
  18. Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations [ Time Frame: Up to 28 months ]
  19. T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations [ Time Frame: Up to 28 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123418


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-4189      
Principal Investigator: Jonathan L. Kaufman         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Althea B Thomas    414-805-5249    Athomas@mcw.edu   
Principal Investigator: Parameswaran Hari         
Australia, Victoria
Novartis Investigative Site Recruiting
Prahran, Victoria, Australia, 3181
Germany
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Israel
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 6423906
Japan
Novartis Investigative Site Recruiting
Bunkyo ku, Tokyo, Japan, 113-8677
Norway
Novartis Investigative Site Recruiting
Oslo, Norway, NO 0450
Spain
Novartis Investigative Site Recruiting
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04123418    
Other Study ID Numbers: CWVT078A12101
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Myeloma, phase 1
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases