Study on Daratumumab for Patients with Multiple Myeloma or Smoldering Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05438043

Provider View

This study aims to provide continued access to the treatment daratumumab for patients with multiple myeloma or smoldering multiple myeloma who are benefiting from it in certain clinical trials. The study will also collect long-term safety data from participants.

Patient Parameters

Program Overview

The purpose of this study is to allow patients with multiple myeloma or smoldering multiple myeloma to continue receiving the treatment daratumumab if they are benefiting from it in specific clinical trials. This includes patients in trials where daratumumab is part of the treatment plan and those in non-daratumumab trials that have reached a point where final results are being analyzed. The study will also gather important safety information from participants over time.

Eligibility Criteria

Inclusion Criteria

  • Currently receiving daratumumab, either alone or with other treatments, in specific clinical trials for multiple myeloma or smoldering multiple myeloma.
  • The trial must have reached a stage where final results are being analyzed, and the patient must still be benefiting from the treatment.
  • No disease progression or severe side effects from daratumumab.
  • Must not have met any criteria for stopping treatment in the original trial.
  • Last dose of treatment must have been within the past 3 months.
  • Doctor believes the benefits of continuing treatment outweigh the risks.
  • Women who can become pregnant must have a negative pregnancy test before starting and agree to regular pregnancy tests during the study.
  • Men must agree not to donate sperm during the study and for at least 3 months after the last treatment dose.
  • Must sign a consent form agreeing to participate and follow study procedures.
  • Willing to follow lifestyle guidelines specified in the study.

Exclusion Criteria

  • Have taken any treatments not allowed between the end of the original trial and the start of this study.
  • Any condition that the doctor believes would not be in the patient's best interest to participate or could interfere with the study.
  • Known allergies or intolerance to the study treatments or their ingredients.
  • Have received any investigational or live vaccines (except COVID-19 vaccines) within 4 weeks before joining the study.

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