Study on Bortezomib and Pembrolizumab With or Without Pelareorep for Treating Relapsed or Resistant Multiple Myeloma (AMBUSH Trial)

Sponsor: University of Southern California

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05514990

Provider View

This clinical trial is testing a combination of drugs, including bortezomib, dexamethasone, and pembrolizumab, with or without pelareorep, to see if they are safe and effective in treating multiple myeloma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a combination of treatments for multiple myeloma, a type of blood cancer that has either come back or is not responding to previous treatments. The study involves using chemotherapy drugs bortezomib and dexamethasone, an immunotherapy drug pembrolizumab, and possibly a virus-based treatment called pelareorep. Researchers want to see if this combination can better control the cancer by stopping its growth and spread.

Description

This study is divided into two phases. In Phase I, the focus is on determining the safety of the drug combinations and finding the best dose for pelareorep when used with bortezomib, dexamethasone, and pembrolizumab. In Phase II, the study will assess how well this combination works in shrinking or controlling the cancer.

Participants will be divided into two groups:

  • Cohort I: Patients will receive bortezomib and dexamethasone, along with pembrolizumab. This treatment is given in cycles, with each cycle lasting 21 days, and can continue for up to 18 cycles unless the cancer progresses or side effects become too severe.

  • Cohort II: Patients will receive the same treatment as Cohort I, but with the addition of pelareorep. This treatment also follows 21-day cycles for up to 18 cycles.

After completing the study, patients will have follow-up visits every 12 weeks or every 6 months, depending on their condition.

Eligibility Criteria

Inclusion Criteria

  • Have multiple myeloma that has returned or is not responding after at least three previous treatments, including specific types of drugs.
  • Have a confirmed diagnosis of multiple myeloma with measurable disease.
  • No ongoing severe side effects from previous treatments.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Agree to use effective contraception during the study and for 7 months after the last treatment.
  • Provide written informed consent to participate in the study.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Meet specific criteria for liver and kidney function.
  • Have normal or mild protein levels in urine.
  • Meet criteria for thyroid and hormone levels.
  • If positive for hepatitis B or C, meet specific criteria for viral load and treatment.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received certain types of cancer treatments or investigational drugs recently.
  • Have a history of severe allergic reactions to study drugs.
  • Have active infections or other serious medical conditions.
  • Have other types of cancer that are progressing or need treatment.
  • Have active brain metastases or certain lung diseases.
  • Have a history of autoimmune diseases requiring treatment.
  • Have a known history of HIV or active hepatitis B or C infections.
  • Have a history of organ or stem cell transplants.
  • Have significant heart disease or mental health conditions that would interfere with the study.
  • Have a history of tuberculosis.

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