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EAA181


Title EAA181: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
Therapeutic Area Multiple Myeloma, Transplant
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04566328?term=NCT04566328&draw=2&rank=1

Overview

To determine if bortezomib, daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab-hyaluronidase SC and lenalidomide (DR) maintenance after standard induction therapy with daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.

Study Details

Inclusion Criteria

1. Participants must have the ability to understand and the willingness to sign an informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be eligible.
2. Participants must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain).
3. Participant must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and should not have received more than one cycle of treatment.
 

Exclusion Criteria

1. Participants must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.
2. Participants must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma.
3. Participants must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
 

Study Requirements

  • If participants meet the requirements in the screening step, they will receive daratumumab, lenalidomide and dexamethasone for 9 cycles (36 weeks) as initial treatment.
    • The length of one cycle of treatment is about 28 days. These first 9 cycles or 36 weeks of treatment are called induction treatment.
    • After 9 cycles, participants will have samples of bone marrow, blood, and urine collected and tested to see whether or not they have any tumor remaining (MRD).
  • After this assessment, participants will be randomly assigned to receive either daratumumab, lenalidomide and dexamethasone with bortezomib added to the treatment, for 9 cycles; OR participants will continue on the same treatment with daratumumab, lenalidomide and dexamethasone for another 9 cycles.
    • This second set of 9 cycles is called consolidation treatment.
  • After completing 9 cycles of consolidation treatment, both groups will receive daratumumab and lenalidomide until either the disease progresses, side effects become too severe or intolerable, or participants/their physicians wish to stop treatment.
  • After finishing treatment, the doctor and study team will watch participants for side effects.
    • They will check on particiapnts every 3 months for 2 years after completion of treatment.
    • After that, they will check every 6 months for 2-5 years.
Then they will follow participants yearly for 15 years.