Comparing Drug Combinations for Treating Newly Diagnosed Multiple Myeloma When Stem Cell Transplant Isn't Suitable

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05561387

Provider View

This study is testing different combinations of drugs to find the best treatment for patients with newly diagnosed multiple myeloma who cannot have a stem cell transplant. The trial focuses on patients who are considered frail or moderately fit due to age or other health conditions.

Patient Parameters

Program Overview

This clinical trial is exploring different drug combinations to treat newly diagnosed multiple myeloma in patients who are not eligible for a stem cell transplant. The study involves initial treatment (induction) followed by ongoing treatment (maintenance) to prevent the cancer from returning. Three combinations of four drugs are being tested: Bortezomib, Lenalidomide, Dexamethasone, and Daratumumab with hyaluronidase-fihj. These drugs work in various ways to stop cancer growth, support normal blood cell production, and reduce inflammation. Patients will receive one of three drug combinations to see which is most effective in controlling multiple myeloma.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse (progression-free survival) when treated with different drug combinations. The study will also look at overall survival rates and how well patients respond to the treatments.

Patients will be divided into three groups:

  • Group 1 (VRd-Lite): Patients receive Bortezomib, Lenalidomide, and Dexamethasone for the first 9 cycles, followed by Lenalidomide alone for maintenance.
  • Group 2 (DRd-R): Patients receive Daratumumab with hyaluronidase-fihj, Lenalidomide, and Dexamethasone for the first 9 cycles, followed by Lenalidomide alone for maintenance.
  • Group 3 (DRd-DR): Patients receive Daratumumab with hyaluronidase-fihj, Lenalidomide, and Dexamethasone for the first 9 cycles, followed by both Daratumumab with hyaluronidase-fihj and Lenalidomide for maintenance.

The study will also assess the safety of these treatments, the quality of life of patients, and the presence of minimal residual disease (MRD) after treatment. Patients will be followed up regularly after completing the study treatment to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of multiple myeloma based on standard criteria.
  • Must have measurable disease, such as specific levels of proteins in the blood or urine.
  • Must be classified as frail or moderately fit using a specific frailty score.
  • Must have adequate blood counts and organ function.
  • Must have a complete medical history and physical exam.
  • Must have whole body imaging, preferably a PET/CT scan.
  • Must have adequate liver and kidney function.
  • Must have controlled diabetes and cardiac function if applicable.
  • Must be willing to provide blood and tissue samples for research.
  • Must be able to complete patient-reported outcomes in English or Spanish.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Must not have received prior systemic therapy for multiple myeloma, except for certain allowed treatments.
  • Must not have severe nerve damage (grade 4 peripheral neuropathy).
  • Must not have uncontrolled high blood pressure.
  • Must not have another cancer that could interfere with the study.
  • Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.

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