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A Phase Ib/II Open-Label Study of APG2575 in Combination with Novel Therapeutic Regimens in Subjects with Relapsed or Refractory Multiple Myeloma and Immunoglobulin Light Chain Amyloidosis

Clinical Trial Details

The purpose of this study is to evaluate the safety and tolerability of the study drug, APG2575 in combination with Pomalidomide and Dexamethasone for both relapsed/refractory multiple myeloma or light chain amyloidosis patients and in combination with Daratumumab, Lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma patients. This study will also look at identifying any dose-limiting toxicities and the maximum tolerated dose of APG-2575.

APG-2575 is an oral medication and  targets a specific protein in your body called BCL-2. When you have hematologic malignancies, this BCL-2 protein may build up and prevent cancer cells from self-destructing naturally. APG-2575 targets BCL-2 in order to help restore this self-destructing process.

There are 3 arms, or cohorts, to this study. Depending on your disease, you will be randomized to the following arms and treatment plans.

Arm A: For participants with relapsed and/or refractory multiple myeloma. Participants will take either 400mg, 600mg, or 800mg of APG2575 orally once daily for 28 days, 4mg of pomalidomide orally on Day 1 through 21, and 40 or 20 mg Dexamethasone orally once a week.

Arm B: For participants with relapsed and/or refractory multiple myeloma. Participants will take either 400mg, 600mg, or 800mg of APG2575 orally once daily for 28 days, 25mg of lenalidomide orally on Day 1 through 21, 40 or 20 mg Dexamethasone orally once a week, and 1800 mg daratumumab injection once a week for the first two cycles, then once bi-weekly. 

Arm C: For participants with light chain amyloidosis. Participants will take APG2575 orally once daily for 28 days, 4mg of pomalidomide orally on Day 1 through 21, and 40 or 20 mg Dexamethasone orally once a week.

Each treatment cycle is 28-days. Treatment will be given in repeated 28-day cycles and will continue until either unacceptable toxicity or disease progression, judgement of the treating physician, or participants choose to withdraw consent at any point in the study.

Key Eligibility: 

Inclusion Criteria:

  1. 18 years of age or older; 
  2. Life expectancy of 6 months or more;
  3. Diagnosed with Relapsed/Refractory Multiple Myeloma (MM), previously treated with at least 1 prior line of therapy.
  4. Participants of childbearing potential agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study drug.

Exclusion Criteria:

  1. Not recovered from recent surgical procedures, or prior treatment based on investigator's discretion.
  2. Active infection needing systemic treatment (including HIV);
  3. Severe medical condition, including, but not limited to, symptomatic congestive heart failure, severe arrhythmias, unstable angina, Plasma cell leukemia, POEMS syndrome, chronic inflammatory diseases or a psychiatric disorder that may affect study adherence. 
  4. Females who are pregnant or breastfeeding.

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2010022740

ClinicalTrials.gov:

NCT04674514

Sponsor:

APG2575MU101

Status

Open to Enrollment

Age Group

Adult

Sponsor