Multiple Myeloma (MM)Phase 1NCT04123418
A Study of WVT078 in Patients With Multiple Myeloma (MM)
A Phase 1 study testing WVT078 and WHG626 in people with Multiple Myeloma (MM), run by Novartis Pharmaceuticals at 12 sites in 8 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- WVT078 and WHG626
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 5 Dec 2019to 2 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
Who cannot join
- 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 locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
United States3 sites
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Germany2 sites
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Heidelberg, 69120
Spain2 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Santander, Cantabria, 39008
About this study
Official title: A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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)
Read the 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.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- WVT078, WHG626
- Keywords
- Multiple Myeloma, phase 1
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WVT078Biological
WVT078 will be administered IV (intravenously) in a dose escalation schedule
WHG626Drug
WHG626 will be administered orally in a dose escalation schedule
| Study group | Role | What they receive |
|---|---|---|
| WVT078 in Multiple Myeloma (MM) patients | Experimental | Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM) Receives: Biological: WVT078 |
| WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients | Experimental | Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM) Receives: Biological: WVT078; Drug: WHG626 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days (first cycle)
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
Measured: Up to 28 months
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
Measured: up to 28 months
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
Measured: up to 28 months
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
Measured: Up to 31 months
Secondary outcomes (19)
Best Overall Response (BOR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: Up to 36 months
Duration of Response (DOR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: Up to 36 months
Progresson Free Survival (PFS)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: Up to 36 months
AUC of WVT078 derived from serum concentrations
Measured: Up to 28 months
Cmax of WVT078 derived from serum concentrations
Measured: Up to 28 months
Cmin of WVT078 derived from serum concentrations
Measured: Up to 28 months
Tmax of WVT078 derived from serum concentrations
Measured: Up to 28 months
T1/2 of WVT078 derived from serum concentrations
Measured: Up to 28 months
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Measured: Up to 28 months
AUC of WHG626 derived from plasma concentrations
Measured: Up to 28 months
Cmax of WHG626 derived from plasma concentrations
Measured: Up to 28 months
Cmin of WHG626 derived from plasma concentrations
Measured: Up to 28 months
Tmax of WHG626 derived from plasma concentrations
Measured: Up to 28 months
T1/2 of WHG626 derived from plasma concentrations
Measured: Up to 28 months
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Measured: Up to 28 months
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Measured: Up to 28 months
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Measured: Up to 28 months
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Measured: Up to 28 months
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start5 Dec 2019
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Why it stopped: The decision was made for business reasons and was not based on any safety or tolerability concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123418
- Sponsor's protocol ID
- CWVT078A12101
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2019
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raab MS, Cohen YC, Schjesvold F, Aardalen K, Oka A, Spencer A, Wermke M, Souza AD, Kaufman JL, Cafro AM, Ocio EM, Doki N, Henson K, Trabucco G, Carrion A, Bender FC, Juif PE, Fessehatsion A, Fan L, Stonehouse JP, Blankenship JW, Granda B, De Vita S, Lu H. Preclinical discovery and initial clinical data of WVT078, a BCMA x CD3 bispecific antibody. Leukemia. 2023 Jun;37(6):1349-1360. doi: 10.1038/s41375-023-01883-3. Epub 2023 Apr 6.
PubMed 37024520
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04123418
- Acronym / sponsor ID
- CWVT078A12101
- Conditions
- Multiple Myeloma (MM)
- Keywords
- Multiple Myeloma, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision was made for business reasons and was not based on any safety or tolerability concerns
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WVT078 in Multiple Myeloma (MM) patients | Experimental | Biological: WVT078Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM) |
| WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients | Experimental | Biological: WVT078, Drug: WHG626Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WVT078WVT078 will be administered IV (intravenously) in a dose escalation schedule | Biological | WVT078 in Multiple Myeloma (MM) patients, WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients |
| WHG626WHG626 will be administered orally in a dose escalation schedule | Drug | WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients |
Primary outcome
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
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
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
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
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
19 secondary outcomes
Best Overall Response (BOR)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progresson Free Survival (PFS)
Time frame: Up to 36 months
AUC of WVT078 derived from serum concentrations
Time frame: Up to 28 months
Cmax of WVT078 derived from serum concentrations
Time frame: Up to 28 months
Cmin of WVT078 derived from serum concentrations
Time frame: Up to 28 months
Tmax of WVT078 derived from serum concentrations
Time frame: Up to 28 months
T1/2 of WVT078 derived from serum concentrations
Time frame: Up to 28 months
Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Time frame: Up to 28 months
AUC of WHG626 derived from plasma concentrations
Time frame: Up to 28 months
Cmax of WHG626 derived from plasma concentrations
Time frame: Up to 28 months
Cmin of WHG626 derived from plasma concentrations
Time frame: Up to 28 months
Tmax of WHG626 derived from plasma concentrations
Time frame: Up to 28 months
T1/2 of WHG626 derived from plasma concentrations
Time frame: Up to 28 months
AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time frame: Up to 28 months
Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time frame: Up to 28 months
Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Time frame: Up to 28 months
Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time frame: Up to 28 months
T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time frame: Up to 28 months
Results and safety
The study was stopped early (reason given: The decision was made for business reasons and was not based on any safety or tolerability concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 37024520Raab MS, Cohen YC, Schjesvold F, Aardalen K, Oka A, Spencer A, Wermke M, Souza AD, Kaufman JL, Cafro AM, Ocio EM, Doki N, Henson K, Trabucco G, Carrion A, Bender FC, Juif PE, Fessehatsion A, Fan L, Stonehouse JP, Blankenship JW, Granda B, De Vita S, Lu H. Preclinical discovery and initial clinical data of WVT078, a BCMA x CD3 bispecific antibody. Leukemia. 2023 Jun;37(6):1349-1360. doi: 10.1038/s41375-023-01883-3. Epub 2023 Apr 6.
- CWVT078A12101 Clinical Trial Results FormLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WVT078 and WHG626 in people with Multiple Myeloma (MM), run by Novartis Pharmaceuticals at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Spain, Australia, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The decision was made for business reasons and was not based on any safety or tolerability concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) in Cycle 1 (time frame: 28 days (first cycle)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04123418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.