Study on Immuno-PRISM: Testing Teclistamab and Comparing with Lenalidomide + Dexamethasone for High-Risk Smoldering Multiple Myeloma

Sponsor: Irene Ghobrial, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05469893

Provider View

This clinical trial is exploring the effectiveness of a new drug, Teclistamab, compared to a combination of Lenalidomide and Dexamethasone in patients with high-risk smoldering multiple myeloma, a condition that can progress to active multiple myeloma.

Patient Parameters

Program Overview

The study aims to test how well Teclistamab works against high-risk smoldering multiple myeloma, a condition where patients have no symptoms but are at risk of developing active multiple myeloma, a type of blood cancer. The trial will compare Teclistamab to a combination of Lenalidomide and Dexamethasone, which are not yet approved for this condition. The study will involve different stages, including screening, treatment, and follow-up, and will last up to 24 months for each participant.

Description

This study involves testing Teclistamab, a new drug, against a standard treatment combination of Lenalidomide and Dexamethasone in patients with high-risk smoldering multiple myeloma. The trial will start with a safety phase where a small group of participants will receive Teclistamab to ensure it is safe. If successful, more participants will be randomly assigned to receive either Teclistamab or the standard treatment. The study will include about 51 participants and will last up to 24 months for each person. The goal is to see if Teclistamab can effectively control the disease compared to the standard treatment. Participants will be closely monitored throughout the study, and the drugs used are considered investigational, meaning they are not yet approved for this specific condition.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have high-risk smoldering multiple myeloma, defined by specific medical criteria.
  • No symptoms of active multiple myeloma, such as high calcium levels, kidney problems, anemia, or bone lesions.
  • Good overall health with a performance status score of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Meet specific blood test requirements, including adequate blood cell counts and organ function.
  • Women of childbearing potential must agree to use effective contraception and undergo regular pregnancy testing if taking Lenalidomide.
  • Men must agree to use condoms during sexual activity and not donate sperm during the study and for 90 days after.
  • Willing to sign informed consent and comply with study procedures.

Exclusion Criteria

  • Have received treatment for smoldering multiple myeloma within the last 6 months.
  • Have active multiple myeloma or symptoms like high calcium levels, kidney problems, anemia, or bone lesions.
  • Have other serious medical or psychiatric conditions that could interfere with the study.
  • Have been treated for another cancer within the last 2 years, with some exceptions for certain non-threatening cancers.
  • Have uncontrolled illnesses, such as infections or heart problems.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have active viral infections like HIV, hepatitis B, or hepatitis C.
  • Have allergies or intolerances to the study drugs.
  • Have received certain treatments or vaccines recently, such as investigational drugs or live vaccines.
  • Have active central nervous system involvement or other specific medical conditions that could affect participation.

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