Study on Iberdomide and Daratumumab as Maintenance Therapy After Stem Cell Transplant for Multiple Myeloma

Sponsor: Barbara Ann Karmanos Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06107738

Provider View

This clinical trial is exploring whether a combination of Iberdomide and Daratumumab can help patients with Multiple Myeloma who still have some cancer cells after a stem cell transplant. The study aims to find out if this treatment is effective and safe for these patients.

Patient Parameters

Program Overview

The purpose of this phase 2 study is to see if Iberdomide and Daratumumab can help patients with Multiple Myeloma who still have minimal residual disease (small amounts of cancer cells) after their initial treatment, including a stem cell transplant. The study will assess if this combination is effective in controlling the disease and if it is safe for patients to use as a maintenance therapy. Participants will undergo various tests and assessments to determine their eligibility and will receive the treatment over a series of cycles, with regular check-ups to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Have Multiple Myeloma and received prior treatment with Daratumumab, showing at least a partial response.
  • Completed a stem cell transplant 90-150 days before joining the study, with no further treatment or disease progression since then.
  • Have minimal residual disease (MRD positive) as confirmed by specific tests after the transplant.
  • Be in good general health with a performance status score of 0 to 2.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified period after.
  • Men must agree to use condoms during sexual contact with women of childbearing potential and not donate sperm during the study and for a specified period after.
  • Be informed about the study and agree to sign a consent form.
  • Be 18 years or older.

Exclusion Criteria

  • Have active HIV or hepatitis C, or a positive test for hepatitis B.
  • Unable to assess MRD status or MRD negative at the required level.
  • Had a heart attack or stroke within 90 days before joining the study.
  • Unable to tolerate required preventive medications for blood clots or infections.
  • Had major surgery within 28 days before joining the study.
  • Have medical conditions that make it unsafe to participate, such as severe heart problems.
  • Had to stop previous Daratumumab treatment due to side effects.
  • Have another type of cancer unless it was treated and resolved at least two years ago.
  • Have lung conditions like severe asthma or COPD that are not well-controlled.
  • Have allergies or intolerances to certain medications used in the study.
  • Be pregnant or breastfeeding, or planning to become pregnant or father a child during the study or shortly after.
  • Have a prolonged QT interval on an ECG test.
  • Use certain medications that affect liver enzymes within 14 days before starting the study treatment.

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