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

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ClinicalTrials.gov Identifier: NCT05259839
Recruitment Status : Not yet recruiting
First Posted : March 2, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
TeneoOne Inc.

Brief 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 ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed.

ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro 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 ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide.

Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro 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.


Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Drug: ABBV-383 Drug: Dexamethasone Drug: Lenalidomide Drug: Pomalidomide Drug: Nirogacestat Drug: Daratumumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Estimated Study Start Date : October 18, 2022
Estimated Primary Completion Date : October 31, 2029
Estimated Study Completion Date : October 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.
Drug: ABBV-383
Intravenous (IV) Infusion

Drug: Dexamethasone
Oral; Tablet or IV Infusion

Drug: Pomalidomide
Oral; Capsule

Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.
Drug: ABBV-383
Intravenous (IV) Infusion

Drug: Dexamethasone
Oral; Tablet or IV Infusion

Drug: Lenalidomide
Oral; Capsule

Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.
Drug: ABBV-383
Intravenous (IV) Infusion

Drug: Dexamethasone
Oral; Tablet or IV Infusion

Drug: Daratumumab
Subcutaneous Injection (SC)

Experimental: Arm D (ABBV-383 with Nirogacestat)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.
Drug: ABBV-383
Intravenous (IV) Infusion

Drug: Nirogacestat
Oral; Tablet




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383 [ Time Frame: Up to approximately 28 Days ]
    DLT events as described in the protocol will be assessed.

  2. Number of Participants with Adverse Events (AEs) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 Disease Negativity (MRD) [ Time Frame: Up to Approximately 3 Years ]
    MRD is defined as the percentage of participants with assessment of the minimal residual disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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 outlined in the protocol.
  • Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
  • Has received prior MM treatment in Arms A, B, C, and D.

Exclusion Criteria:

  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug 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.
  • Known central nervous system involvement Multiple Myeloma (MM).
  • Has any of the following conditions:

    • Nonsecretory 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 drug 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.
  • Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

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): NCT05259839


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 46 study locations
Sponsors and Collaborators
TeneoOne Inc.
Investigators
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Study Director: TeneoOne Inc TeneoOne Inc.
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Responsible Party: TeneoOne Inc.
ClinicalTrials.gov Identifier: NCT05259839    
Other Study ID Numbers: M22-947
2021-005587-22 ( EudraCT Number )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by TeneoOne Inc.:
Relapsed/Refractory Multiple Myeloma
Pomalidomide
Dexamethasone
Lenalidomide
Daratumumab
Nirogacestat
ABBV-383
Cancer
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
Dexamethasone
Lenalidomide
Daratumumab
Pomalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors