Clinical Trial 22100

• Overview

  Study 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

  Summary:

  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.

  Objective:

  Primary Objectives: To characterize the safety and toxicity profiles of ABBV-383 when co-administered with pomalidomide-dexamethasone, lenalidomide-dexamethasone, daratumumab-dexamethasone, or nirogacestat in subjects with R/R MM. To determine the recommended Phase 2 dose of ABBV-383 when given in combination with anti-myeloma regimens (pomalidomide-dexamethasone, lenalidomide-dexamethasone, or daratumumab-dexamethasone) or nirogacestat in R/R MM. Secondary Objectives: To evaluate the anti-MM activity of ABBV-383 when given in combination with anti-myeloma regimens (pomalidomide-dexamethasone, lenalidomide-dexamethasone, or daratumumabdexamethasone) or nirogacestat. To characterize the pharmacokinetic (PK) of ABBV-383 when given in combination with anti-myeloma regimens (pomalidomide-dexamethasone, lenalidomide-dexamethasone, or daratumumab-dexamethasone) or nirogacestat. To evaluate the immunogenicity of ABBV-383. To characterize the PK of nirogacestat when given in combination with ABBV-383 (Arm D only).

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  CC-4047 (Pomalidomide); CC-5013 (Lenalidomide); Daratumumab (Darzalex); Dexamethasone (); Lenalidomide (Revlimid); Nirogacestat (); Pomalidomide (); abbv-383 (Etentamig)

• Inclusion Criteria

  Inclusion Criteria:
  • Eastern Cooperative Oncology Group (ECOG) performance of less than or equal to 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.
  • Other criteria may apply

• Exclusion Criteria

  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 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
  • 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 greater than or equal to Grade 3 or greater than or equal to Grade 2 with pain within 2 weeks prior to first dose.
  • Other exclusions may apply

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