NUTRIVENTION-4

A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide

What's the purpose of the trial?

The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. 

Trial status

Accepting patients

Phase
Phase 2
Enrollment
100
Last Updated
5 months ago
Patient Screener

Participating Centers

There are 7 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Lenalidomide Maintenance

Accepting patients

Daratumumab Maintenance

Published Results

Explore published results and other resources associated with this clinical trial (including press releases, news articles and videos).

Daratumumab Versus Lenalidomide As Maintenance Therapy in Newly Diagnosed Multiple Myeloma – Interim Efficacy Results of a Randomized Clinical Trial

Results: At data cutoff in June 2024, 86 pts have been enrolled of whom 74 were evaluable (37 in len arm, 37 in dara arm) with a median follow up of 19.3 months. Of the 74 pts, median age was 70 with 44.6% ≥65yrs, 56.7% male; 70.3% White, 20.3% Black, 1.3% Asian and 8.1% other races. High risk cytogenetics were present in 32.4% in dara arm and 24.3% in len arm. In the len arm, 51.3% received quadruplets, 46% triplets and 1 pt received infusional chemotherapy. In the dara arm, 51.4% received quadruplets while 48.6% pts received triplet regimens. Dara during induction was received by 64.8% in dara arm and 56.7% in the len arm. ASCT was done in 81.1% of the len arm and 75.6% of the dara arm. Best responses to date in the len arm included 48.6% stringent complete response (sCR), 29.7% CR, 18.9% VGPR and 2.7% progression of disease and in the dara arm 70.2% sCR, 18.9% CR and 10.9% VGPR. Among those , MRD negativity was achieved at screening, year 1 and year 2 in len arm (43.2% [16/37], 48.1% [13/27], 64.3% [9/14]) and in dara arm (51.4% [19/37], 59.1% [13/22], 71.4% [10/14]) respectively. Pts on len arm demonstrated 12-month PFS of 89.7% (n=21) and 24-month PFS of 74.4% (n=9) while pts on dara arm 12-month PFS of 93.3% (n=24) and 24month PFS of 83.1% (n=10). Of 17 pts that came off the study prior to end of treatment, 11 were due to disease progression (6 in len arm; 5 in dara arm) and 6 due to other reasons [len arm - neuropathy (n=2), arthralgia (n=1); dara arm - pneumonitis (n=1), osteomyelitis (n=1) and new CML needing treatment (n=1)].

Conclusions: The study enrolled a racially diverse population and early efficacy data suggest similar best response rates and 12- and 24-month PFS between dara and len arms. These data add to ongoing trials utilizing anti-CD38 monoclonal antibodies (mAbs) as part of maintenance strategies (NCT04071457; NCT03617731). Given encouraging efficacy signals, antiCD38mAbs may be considered an effective maintenance strategy, especially in pts with len intolerance. Updated data will be presented at the meeting.

1 month ago Read more

Real People. Real Support.

Need help connecting with this clinical trial? We're here to help!

Print a patient-friendly report to share with your patient.

We can help answer any questions and connect you (or your patient) with the study team.

Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.