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Safety and Efficacy of ABBV-453 in Monotherapy or in Combination with Antimyeloma Regimens

The purpose of Substudy 1 is to characterize the safety and tolerability of ABBV-453 in combination with other antimyeloma agents in subjects with Relapsed or Refractory (R/R) Multiple Myeloma (MM) and to determine the recommended Phase 2 doses (RP2D) of ABBV-453 in combination with daratumumab + dexamethasone (Dd) in subjects with R/R MM.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

During screening, the following procedures will be performed: medical/oncology history, adverse event assessment, current and previous medications, performance status, electrocardiogram, physical examination and vital signs, blood and urine collection, viral serologies, pregnancy test (for women of child-bearing potential), bone marrow aspirate, bone marrow core biopsy, BCL2 and t(11;14) central testing, skeletal survey, plasmacytoma evaluation, and tumor lysis syndrome (TLS) prophylaxis. In addition to the procedures described above, the following procedures will be performed during study cycles: biomarker research, pharmacokinetic (PK) testing, response assessment, infection prophylaxis, study diary, study drug dispensation, post-treatment follow-up visits, and survival follow-up visits.

Incentives

ABBV-453 will be provided at no charge.

In-person visits:
This will depend on the length of your participation in the study.
Phone or online visits:
The 30-day follow-up and survival follow-up can be done by phone.
Total length of participation:
Your participation may last approximately 1.5 years. Depending on how well this study drug works for you, the length of your participation may change.

Looking for Specific Volunteers

Able to participate:

  • You are at least 18 years old.
  • You have a diagnosis of multiple myeloma.
  • Your multiple myeloma has come back/worsened after being treated initially OR has not responded to treatment.
  • You are able to take an oral medication.

Not eligible if:

  • You have active hepatitis B or C infection.
  • You have evidence of ongoing graft-versus-host disease.
  • You have a history of plasma cell leukemia, primary amyloidosis, or POEMS syndrome.
  • You have a history of significant heart disease.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

25-0625

ClinicalTrials.gov

NCT06953960

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