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Multiple MyelomaPhase 1NCT04570631

Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing Eftozanermin alfa, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 19 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Eftozanermin alfa, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
19 sitesin 6 countries
Study dates
5 Nov 2020to 5 May 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
  • Has measurable disease at screening, defined by at least 1 of the following:
  • Serum M-protein >= 1.0 g/dL (>= 10 g/L); OR
  • Urine M-protein >= 200 mg/24 hours; OR
  • Serum free light chain (sFLC) >= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
  • Relapsed or refractory MM after receiving at least 3, but no more than 6 prior lines of therapy, including an immunomodulatory agent (IMiD), proteasome inhibitor (PI), and an anti-CD38 antibody, and has documented disease progression that occurred during or after the most recent therapy.
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  • Has adequate hematologic, hepatic and renal function as defined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Life expectancy >= 12 weeks.

Who cannot join

  • Received bortezomib as part of the most recent prior therapy.
  • Has primary refractory disease defined as disease that is non-responsive.
  • Has not achieved a minimal response or better per IMWG criteria with any therapy.
  • Has discontinued bortezomib due to toxicity.
  • History of chronic liver disease or significant unresolved liver disease; currently active (within the last 6 months) hepatic impairment according to Child-Pugh Classification B or C.
  • History of cataract surgery within 6 months prior to study treatment and participant is not anticipated to have cataract surgery during the study treatment period (as assessed by ophthalmological exam at baseline).
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  • Evidence of (as assessed by ophthalmological exam at baseline) uveitis, neovascular age related macular degeneration, retinal vein or artery occlusion and/or macular edema; no evidence of moderate or worsening diabetic retinopathy, retinal vascular disease or glaucoma (including participants with history of developing increased intraocular pressure after corticosteroid treatment) per clinical discretion of the consulting eye specialist.
  • Peripheral neuropathy Grade >= 2 or Grade 1 with pain.
  • Receipt of one of the following:
  • Corticosteroids at a dose equivalent to > 4 mg daily of dexamethasone or a single dose of > 40 mg of dexamethasone within 2 weeks prior to first dose.
  • Monoclonal antibodies used for multiple myeloma treatment within 4 weeks prior to first dose of study treatment.
  • Any other systemic therapies used for multiple myeloma treatment within 5 half-lives or 2 weeks prior to first dose, whichever is longer (or 2 weeks if half-life is unknown).

Trial locations and contacts

19 sites in 6 countries.

19 sites in 6 countries

United States5 sites

  • Duplicate_Emory University, Winship Cancer Institute /ID# 222922

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute /ID# 222174

    Boston, Massachusetts, 02215

  • University of Texas Southwestern Medical Center /ID# 223811

    Dallas, Texas, 75390-7208

  • Duke University Medical Center /ID# 222166

    Durham, North Carolina, 27710

  • Norton Healthcare Pavilion /ID# 222918

    Louisville, Kentucky, 40202

Other trials in United States

France5 sites

  • CHRU Lille - Hopital Claude Huriez /ID# 222302

    Lille, Nord, 59037

  • Institut Paoli-Calmettes /ID# 222307

    Marseille, Bouches-du-Rhone, 13009

  • CHU de Nantes, Hotel Dieu -HME /ID# 222303

    Nantes, Pays de la Loire Region, 44000

  • HCL - Hopital Lyon Sud /ID# 222304

    Pierre-Bénite, Rhone, 69495

  • Institut Gustave Roussy /ID# 223951

    Villejuif, Val-de-Marne, 94805

Other trials in France

Germany4 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 223014

    Berlin, 12203

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 222258

    Hamburg, 20246

  • Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222372

    Mainz, Rhineland-Palatinate, 55131

  • Duplicate_Universitaetsklinikum Muenster /ID# 222504

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Italy2 sites

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 223839

    Meldola, Reggio Emilia, 47014

  • Duplicate_Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita /ID# 223224

    Rome, Lazio, 00168

Other trials in Italy

Japan2 sites

  • National Cancer Center Hospital East /ID# 239436

    Kashiwa-shi, Chiba, 277-8577

  • Nagoya City University Hospital /ID# 222408

    Nagoya, Aichi-ken, 467-8602

Other trials in Japan

Spain1 site

  • Hospital Duran i Reynals /ID# 222329

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Official title: A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM.

Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world.

Read more

Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

Being tested
Eftozanermin alfa, Bortezomib, Dexamethasone
Keywords
Multiple Myeloma (MM), Relapsed/Refractory Multiple Myeloma, Eftozanermin Alfa, ABBV-621, Bortezomib, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eftozanermin alfaDrug

    Also called ABBV-621

    Intravenous (IV) infusion

  • BortezomibDrug

    Intravenous (IV) or Subcutaneous (SC) injection

  • DexamethasoneDrug

    Oral Tablet

Study groups in NCT04570631
Study groupRoleWhat they receive
Safety Lead-inExperimentalParticipants will receive escalating doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine recommended phase 2 dose (RP2D).
Receives: Drug: Eftozanermin alfa; Drug: Bortezomib; Drug: Dexamethasone
Dose ExpansionExperimentalParticipants will receive eftozanermin alfa at RP2D determined in Safety Lead-in part in combination with bortezomib and dexamethasone.
Receives: Drug: Eftozanermin alfa; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D) of Eftozanermin Alfa in Combination With Bortezomib and Dexamethasone (Safety Lead-In Arm)

    RP2D of eftozanermin alfa in combination with bortezomib and dexamethasone will be determined.

    Measured: Up to approximately 3 weeks after the first dose of study drug

  2. Objective Response Rate (ORR) (Dose Expansion Arm)

    ORR is defined as percentage of participants with a response of partial response (PR) or better per International Myeloma Working Group (IMWG) criteria.

    Measured: Up to approximately 44 weeks after the first dose of study drug

Secondary outcomes (11)

  1. Rate of Very Good Partial Response (VGPR) or Better per IMWG Criteria

    Percentage of participants with a response of VGPR or better per IMWG criteria will be assessed.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  2. Duration of Response (DOR) for ORR

    DOR for ORR is defined as the number of days from the date of first response (PR or better) to the date of first occurrence of progressive disease (PD) or death from any cause, whichever occurs first.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  3. Duration of Response (DOR) for VGPR or Better

    DOR for VGPR or better rate is defined as the number of days from the date of first response (VGPR or better) to the date of first occurrence of PD or death from any cause, whichever occurs first.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  4. Number of Participants With Dose-Limiting Toxicities (DLTs)

    DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of study drug as described in the protocol and evaluated by the Investigator and the sponsor.

    Measured: Up to approximately 3 weeks after the first dose of study drug

  5. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  6. Change in Vital Sign Measurements

    Change from baseline in vital sign measurements such as systolic and diastolic blood pressure will be assessed.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  7. Electrocardiogram (ECG)

    Participants with change from baseline in ECG variables will be assessed.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  8. Number of Participants With Abnormal Clinical Laboratory Test Results

    Number of participants with abnormal clinical laboratory test results like hematology will be assessed.

    Measured: Up to approximately 44 weeks after the first dose of study drug

  9. Trough Concentration (Ctrough) of Eftozanermin Alfa

    Serum concentration prior to administration of study drug.

    Measured: Up to Day 106

  10. Maximum Serum Concentration (Cmax) of Eftozanermin Alfa

    Serum concentration at 15 min after end of infusion.

    Measured: Up to Day 8

  11. Antidrug Antibody (ADA)/Neutralizing Antibody (Nab) Assay

    Serum sample assay for ADA/Nab (Nabs will be analyzed only upon request).

    Measured: Up to approximately 44 weeks after the first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start5 Nov 2020
  3. Primary completion5 May 2025
  4. Study completion5 May 2025

Why it stopped: Strategic considerations

Resources

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04570631
Sponsor's protocol ID
M20-258
Other IDs
2020-001983-26
Status last verified
May 2025
First submitted
23 Sep 2020
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eftozanermin alfa, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 19 sites in 6 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 9 inclusion and 12 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, France, Germany, Italy, Japan and 1 more country. 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: Strategic considerations). 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?

Recommended Phase 2 Dose (RP2D) of Eftozanermin Alfa in Combination With Bortezomib and Dexamethasone (Safety Lead-In Arm) (time frame: Up to approximately 3 weeks after the first dose of study drug). The study lists 2 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 NCT04570631.

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 16 May 2025.

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