Relapsed or Refractory Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864 MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Sponsors
Autolus Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged = 18. 2. Willing and able to give written, informed consent for both, the current study protocol AUTO2-MM1 and the associated long term follow up study AUTO2-LT1. 3. Confirmed diagnosis of MM as per IMWG. 4. Measurable disease as defined by IMWG, any 1 of the following: - Serum M-protein = 500 mg/dL; - Urine M-protein = 200 mg/24 hours; - Involved serum free light chain level = 10 mg/dL, provided serum free light chain ratio is abnormal. 5. At least 2 previous anti myeloma treatments (which between them must have included alkylator therapy, an immunomodulatory drug and a proteasome inhibitor). 6. Relapsed or refractory disease (refractory defined as either progression on previous regimen or progression within 60 days of stopping previous regimen). Relapse as defined by IMWG criteria. 7. For females of childbearing potential (defined as 0.5 x 109/L. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating. 2. Prior treatment with investigational or approved gene therapy or cell therapy products. 3. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischaemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 6 months) cardiac event. 4. Left Ventricular Ejection fraction 2.0 mg/dL or evidence of end stage liver disease (e.g. ascites, hepatic encephalopathy). 8. Chronic renal impairment requiring dialysis, or calculated creatinine clearance 7 days post dose prior to pre-conditioning or leukapheresis. 13. Received any radiotherapy within the last 21 days prior to pre-conditioning or 10 days prior to leukapheresis. Localised radiation therapy to a single site, e.g. for bone pain within last 7 days is acceptable. 14. Life expectancy < 3 months. 15. Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: Assess the safety and tolerability of AUTO2, establish the recommended Phase II dose & maximum tolerated dose, where applicable. Phase 2: To evaluate the anti-tumour effect, safety and tolerability of AUTO2. ;Secondary Objective: - Evaluate the feasibility of generating the ATIMP - Evaluate the clinical efficacy of AUTO2 - Assess biomarker and pharmacodynamics effects of AUTO2 ;Primary end point(s): Phase 1: Assess the safety and tolerability of AUTO2 administration. - Identify the recommended Phase II dose and maximum tolerated dose, if applicable. Phase 2: Evaluate the anti-tumour effect, safety and tolerability of AUTO2.;Timepoint(s) of evaluation of this end point: Phase 1: End of Phase I or 12 months post-AUTO2 administration of the last patient, unless in the event of death or early withdraw, which would default to the preceding patient's completion timepoint. Phase 2: Within 6 months and 12 months post-AUTO2 administration of the last patient unless in the event of death or early withdraw, which would default to the preceding patient's completion timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluate the feasibility of generating the ATIMP - Evaluate the clinical efficacy of AUTO2. - Assess biomarker and pharmacodynamics effects of AUTO2. ;Timepoint(s) of evaluation of this end point: Within 6 and 12 months following AUTO2 infusion, or in the event of an earlier outcome on the last patient entered onto the study. | — |
Countries
Netherlands, United Kingdom
Contacts
Public ContactClinical Project Manager
Autolus Limited
Outcome results
None listed