Multiple Myeloma
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 18 years and older • Be able to read, understand and give informed consent • Have MM and belong to 1 of the following subgroups: Group 1A: MM patients, triple refractory Group 2A: MM patients, treated with BsAbs, either on treatment or within 3 months after discontinuation Group 1B: MM patients having received first line treatment only Group 1C: Newly diagnosed MM patients Group 2B: MM patients > 3 months after BsAbs treatment discontinuation • For the full scale experiment: the haemoglobin level should be > 6.5 mmol/L, lower haemoglobin levels (5,0-6,5 mmol/L) are accepted when blood withdrawal is combined with an already scheduled routine blood transfusion.
Exclusion criteria
Exclusion criteria: • not being able to give informed consent • A lymphocyte count of < 0.5 x 10^9/L • Use of corticosteroids > 20 mg a day in the 7 days before blood withdrawal. The same counts for any other immunosuppressant drug • Haemoglobin level < 5,0 mmol/L • For the full scale experiment: any condition which may possibly interfere with the safety of extra blood withdrawal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We define effective production of CAR T-cells from patient blood as follows: - Minimum expansion of 5-fold. - >65% effective killing of myeloma cells - 15-50% T cell transduction with a GMP-grade retroviral vector - Viability of > 80 % Successful: when >=4 out of 5 experiments per group meet these endpoints Unsuccessful: when <4 out of 5 experiments per group meet these endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed