This trial is aiming to examine the effectiveness of combination therapy with venetoclax (Venclexta), daratumumab (Darzalex), and dexamethasone (Ozurdex) with or without bortezomib (Velcade) for unresponsive or relapsed multiple myeloma (MM). The main outcome that is to be measured is the response rate, time to response, and the duration of the response.
MM is a cancer that comes from blood cells called plasma cells. Many treatment combinations are used in the treatment of MM. However, MM can become refractory (unresponsive) or relapsed (r/r) and starts to spread. Therefore, other treatment combinations are needed for these patients.
This trial is evaluating the combination of venetoclax, daratumumab, and dexamethasone (VenDd) with or without bortezomib for patients with r/r MM. The main outcomes to be measured are the response to treatment, time to response, and duration of the response to this drug combination.
Who are they looking for?
This trial is looking for 104 patients with MM that has worsened on or after the last treatment. Patients will be included if they agree to have a sample of their bone marrow taken, have adequate blood cell counts, and good kidney and liver function.
Patients will be excluded from this trial if they have previously been treated with the drugs used for this study or have received other anti-cancer therapy or corticosteroids such as dexamethasone within 2 weeks of starting this trial. Patients will also be excluded if they have MM spread to their brain, serious medical conditions, or other cancers within the last 3 years.
How will it work
There will be 3 parts to this trial. During part 1, participants will receive VenDd. In part 2, participants will receive VenDd in combination with bortezomib. In part 3, participants will receive VedDd with or without bortezomib. in varying doses and in different cycles. In parts 1 and 2, participants will no be randomly assigned, while in part 3 participants will randomly be assigned to one of the treatment options.
Treatment response and survival will be evaluated for up to 3.5 years.