This trial is comparing the effectiveness of a new therapy, bb2121, to commonly used combinations of drugs for relapsing/refractory (unresponsive) multiple myeloma (RRMM). The main outcome to be measured is the time from the start of treatment until cancer worsens.
Many patients are cured with standard treatments, such as chemotherapy, for multiple myeloma. However, some patients may lose response over time (relapse). Others may not respond to treatments at all (refractory). Bb2121 is a new therapy for RRMM. This is a type of cell therapy which uses the patient’s own blood cells to attack and kill tumor cells. It is important to investigate the effects and safety of bb2121 in patients with RRMM.
The main outcome will be the time it takes for cancer worsening after 5 years.
Who are they looking for?
381 patients will be recruited. To participate in this study patients must have been treated with at least 2 MM therapies and must have been unresponsive to the last treatment. They must have also previously responded (at least minimally) to at least one treatment before. Patients must have mostly recovered from any serious non-blood related side effects from previous treatments before participating.
To participate, the patient must not have any condition that may interfere with measuring the effects of the treatments. The patient cannot have had another cancer in the 5 years before participating in the study. The patient cannot have used any experimental MM treatments in the 28 days before participating in the study. In the 14 days before participating in the study, the patient may not have received a plasma infusion, surgery or any intravenous treatment for MM.
How will it work
This study will include 2 groups of patients. Patients in group 1 will receive chemotherapy followed by bb2121 treatment. Patients in group 2 will receive treatment with a combination of 3 standard anti-cancer drugs. This may include daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone (Decadron). The second combination includes daratumumab with bortezomib (Velcade) and low-dose dexamethasone. The third combination involves ixazomib (Ninlaro) in combination with lenalidomide (Revlimid) and low-dose dexamethasone.
Patients will be followed up to 5 years. The main outcomes to be measured will be survival without the disease worsening, overall survival, and side effects.