Study on Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treating Newly Diagnosed Multiple Myeloma (IDEAL Study)

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05392946

Provider View

This clinical trial is testing a new combination of drugs to treat patients who have been newly diagnosed with multiple myeloma, a type of blood cancer. The study aims to find the best dose of iberdomide and see how well it works with other medications to stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with newly diagnosed multiple myeloma, a type of blood cancer. The treatment combines four drugs: iberdomide, daratumumab, bortezomib, and dexamethasone. Iberdomide is an immunotherapy that may help the body's immune system fight cancer. Daratumumab is an antibody that targets cancer cells, while bortezomib and dexamethasone are drugs that stop cancer cells from growing. The study aims to find the best dose of iberdomide and see how well this combination works in reducing cancer cells.

Description

The IDEAL study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of iberdomide when combined with daratumumab, bortezomib, and dexamethasone. In Phase II, the study will evaluate how well this combination works in treating newly diagnosed multiple myeloma.

During the induction phase, patients will take iberdomide by mouth daily for 21 days, receive bortezomib under the skin on specific days, and take dexamethasone by mouth on certain days. Daratumumab will be given under the skin on a schedule that changes over time. This treatment cycle repeats every 28 days for up to 12 cycles, as long as the cancer does not progress and side effects are manageable.

In later cycles (13-36), patients will continue taking iberdomide by mouth daily for 21 days, with treatment cycles repeating every 28 days, again depending on cancer progression and side effects.

Throughout the study, patients will undergo various tests, including bone marrow biopsies, imaging scans, and blood tests, to monitor their response to the treatment. After completing the study treatment, patients will have follow-up visits at 30 days and then every six months for three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have newly diagnosed active multiple myeloma or have received no more than one cycle of treatment for it.
  • Have measurable disease, such as specific levels of proteins in the blood or urine, or certain sizes of tumors.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use contraception and not donate sperm during and after treatment.
  • Provide written informed consent.
  • Agree to provide bone marrow samples for research purposes.
  • Be willing to follow study procedures and attend follow-up visits.

Exclusion Criteria

  • Have conditions like monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis.
  • Be pregnant or breastfeeding.
  • Be unwilling to use adequate contraception if of childbearing potential.
  • Be receiving other investigational treatments.
  • Have active infections or other serious medical conditions.
  • Have uncontrolled heart or lung disease.
  • Have a history of severe allergic reactions to study drugs.
  • Have had major surgery or plasmapheresis recently.
  • Have received certain medications or treatments that could interfere with the study.
  • Have other cancers unless in remission for at least five years, with some exceptions for noninvasive cancers.

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