Study on Subcutaneous Daratumumab, Weekly Carfilzomib, and Dexamethasone for High-Risk Smoldering Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04933539

Provider View

This clinical trial is testing a combination of three drugs to see if they can prevent or slow down the progression of high-risk smoldering multiple myeloma, a condition that can lead to more serious multiple myeloma.

Patient Parameters

Program Overview

The study aims to find out if a combination of drugs—daratumumab, carfilzomib, and dexamethasone—can help prevent or slow down the development of multiple myeloma in patients with high-risk smoldering multiple myeloma. This condition involves abnormal plasma cells in the bone marrow that can lead to organ damage if it progresses. Participants will receive these drugs in cycles, with the goal of reducing the risk of the disease becoming more serious.

Description

Smoldering multiple myeloma (SMM) is a condition where abnormal plasma cells are present in the bone marrow, but it hasn't yet caused symptoms or organ damage. People with high-risk SMM have a high chance of developing multiple myeloma within a few years. Currently, the standard approach is to monitor the condition closely without treatment until it progresses. However, this study is exploring whether early treatment with a combination of drugs can help.

Participants will receive a combination of three drugs: daratumumab (given as an injection under the skin), carfilzomib (given through an IV), and dexamethasone (taken as a pill or through an IV). This treatment will be given in 28-day cycles. After 8 cycles, if the disease hasn't improved enough, participants may receive 4 more cycles. After this, they will continue with daratumumab alone for up to 24 cycles.

Throughout the study, participants will have regular visits for blood tests, scans, and other evaluations to monitor their health and the treatment's effects. They will also have follow-up visits after the treatment ends to continue monitoring their condition.

Eligibility Criteria

Inclusion Criteria

  • Must have smoldering multiple myeloma (SMM) as defined by specific medical criteria.
  • Must be at least 18 years old.
  • Must have good overall health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ and bone marrow function based on specific blood test results.
  • Must be classified as high-risk SMM according to certain criteria, such as specific levels of abnormal proteins or plasma cells in the blood or bone marrow.
  • Must agree to use effective contraception during the study and for a period after treatment if they can have children.

Exclusion Criteria

  • Cannot be receiving any other investigational treatments.
  • Cannot have had prior therapy for SMM, with some exceptions.
  • Cannot have certain medical conditions, such as severe lung disease or uncontrolled asthma.
  • Cannot have active infections like hepatitis B or C, or HIV unless well-controlled.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot have uncontrolled high blood pressure or diabetes.
  • Cannot have significant heart disease or recent heart attack.
  • Cannot be pregnant or breastfeeding, as the effects of the drugs on a developing baby or nursing infant are unknown.
  • Cannot have other serious health issues that would interfere with the study.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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