Study on DARA RVD for High-Risk Smoldering Multiple Myeloma

Sponsor: Omar Nadeem, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04775550

Provider View

This clinical trial is testing a combination of four drugs to see if they can treat smoldering multiple myeloma and prevent it from becoming active. The drugs being studied are Darzalex Faspro, Velcade, Revlimid, and dexamethasone.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of four drugs—Daratumumab (Darzalex Faspro), Lenalidomide (Revlimid), Bortezomib (Velcade), and Dexamethasone—can effectively treat smoldering multiple myeloma and stop it from progressing to active multiple myeloma. These drugs are being tested together as an investigational treatment, meaning they haven't been approved by the FDA for this specific use. Participants will be treated for up to 24 months and followed for up to 3 years. About 30 people are expected to join this Phase II clinical trial, which aims to test the effectiveness of this drug combination.

Description

This study is exploring whether a combination of four drugs can help treat smoldering multiple myeloma and prevent it from becoming active. The drugs involved are Daratumumab (Darzalex Faspro), Lenalidomide (Revlimid), Bortezomib (Velcade), and Dexamethasone. These drugs are considered investigational when used together for this condition, meaning they haven't been approved by the FDA for this specific purpose.

Participants will undergo screening to determine eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. The treatment period can last up to 24 months, with follow-up continuing for up to 3 years. The study aims to enroll about 30 participants.

This is a Phase II clinical trial, which means it is focused on testing how effective the investigational drug combination is. The study drugs are Daratumumab (Darzalex Faspro), Lenalidomide (Revlimid), Bortezomib (Velcade), and Dexamethasone. The FDA has not approved this combination for treating smoldering multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older.
  • Diagnosed with high-risk smoldering multiple myeloma, meeting specific criteria such as:
    • Bone marrow plasma cells 10% or more with additional risk factors like high serum M protein or abnormal immunoglobulin levels.
    • Progressive increase in M protein level.
    • High-risk genetic markers or specific imaging findings.
  • No evidence of active multiple myeloma symptoms like high calcium levels, kidney issues, anemia, or bone lesions.
  • ECOG performance status of 0, 1, or 2, indicating good overall health.
  • Specific blood test results within normal ranges.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Participants must be registered in the Revlimid REMS program and comply with its requirements.
  • Men must agree to use condoms during sexual contact with women of childbearing potential.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Symptoms of active multiple myeloma or evidence of myeloma-defining events.
  • Current treatment with other investigational therapies, except for certain allowed treatments like bisphosphonates.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Recent diagnosis or treatment for another cancer, except for certain low-risk cancers.
  • Uncontrolled illnesses like infections, heart failure, or psychiatric conditions.
  • Pregnant or nursing women.
  • Allergic reactions to similar drugs.
  • Active viral infections like HIV, hepatitis B or C, or COVID-19, unless specific conditions are met.
  • Severe lung conditions like COPD or asthma with low lung function.

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