A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

NCT05259839
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
283
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Lead sponsor
AbbVie
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Start date
2022-10-20
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Number of sites
49
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Summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide. Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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Short title
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
clinicaltrials.gov
Official title
A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2033-09-01
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First posted
2022-03-02
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Registry last updated
2026-08-14
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Primary completion date
2033-09-01
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Start date
2022-10-20
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Actual participants
283
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Participants
283
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
49
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05259839
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ClinicalTrials.gov ID
NCT05259839
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig

    Timeframe: Up to approximately 28 Days

    DLT events as described in the protocol will be assessed.

  2. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to Approximately 3 Years

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  1. Overall Response Rate (ORR)

    Timeframe: Up to Approximately 3 Years

    ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.

  2. Progression-Free Survival (PFS)

    Timeframe: Up to Approximately 3 Years

    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.

  3. Duration of Response (DOR)

    Timeframe: Up to Approximately 3 Years

    DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.

  4. Time-to-Progression (TTP)

    Timeframe: Up to Approximately 3 Years

    TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.

  5. Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)

    Timeframe: Up to Approximately 3 Years

    MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with \>= CR (per International Myeloma Working Group \[IMWG\] response criteria) prior to the initiation of new myeloma therapy.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
  • Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
  • Must have measurable disease as determined by central lab as outlined in the protocol.
  • Must be naïve to treatment with Etentamig.
  • Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
  • Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
  • Arm E: Participant has received 1-3 prior lines of MM treatment.

  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.

  • Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.

  • Has any of the following conditions:

    • Nonsecretory Multiple Myeloma (MM).
    • Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
    • Waldenstrom's macroglobulinemia.
    • Light chain amyloidosis.
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
    • Major surgery within 4 weeks prior to first dose or planned study participation.
    • Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
    • Uncontrolled diabetes or hypertension within 14 days prior to first dose.
    • Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
Sources for eligibility
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  • University of Arkansas for Medical Sciences /ID# 243096Little Rock, United States
  • Sylvester Comprehensive Cancer Center /ID# 243673Miami, United States
  • Moffitt Cancer Center /ID# 243437Tampa, United States
  • University of Maryland, Baltimore /ID# 243679Baltimore, United States
  • Dana-Farber Cancer Institute /ID# 249529Boston, United States
  • University of Massachusetts - Worcester /ID# 243977Worcester, United States
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438Ann Arbor, United States
  • The Valley Hospital /ID# 243829Paramus, United States
  • Rutenberg Cancer Center /ID# 244647New York, United States
  • Memorial Sloan Kettering Cancer Center /ID# 244656New York, United States
  • Atrium Health Levine Cancer Institute /ID# 242851Charlotte, United States
  • University of Texas - Southwestern Medical Center /ID# 243273Dallas, United States
  • Huntsman Cancer Institute /ID# 242872Salt Lake City, United States
  • University of Washington /ID# 243172Seattle, United States
  • Froedtert Memorial Lutheran Hospital /ID# 242654Milwaukee, United States
  • St George Hospital - Kogarah /ID# 243740Kogarah, Australia
  • Calvary Mater Newcastle /ID# 243730Waratah, Australia
  • Monash Health - Monash Medical Centre - Clayton /ID# 244403Clayton, Australia
  • St Vincent's Hospital Melbourne /ID# 256879Fitzroy Melbourne, Australia
  • Peter MacCallum Cancer Ctr /ID# 256880Melbourne, Australia
  • Epworth Healthcare /ID# 243734Richmond, Australia
  • Fiona Stanley Hospital /ID# 244753Murdoch, Australia
  • Universitaetsklinikum Tuebingen /ID# 242815Tübingen, Germany
  • Universitaetsklinikum Regensburg /ID# 242837Regensburg, Germany
  • Universitaetsklinikum Wuerzburg /ID# 242826Würzburg, Germany

And 24 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506871-88-00
Sources for references
clinicaltrials.gov

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