A phase I/II dose escalation study evaluating safety and activity of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-alfa2 gene in multiple myeloma patients with early relapse after intensive front line therapy - TEM-MM

OSPEDALE SAN RAFFAELE0 sites3 target enrollmentJune 12, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple myeloma in early relapse after intensive front line therapy
Sponsor: OSPEDALE SAN RAFFAELE
Enrollment: 3
Status: Active, not recruiting
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

June 12, 2019

End Date

November 11, 2021

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OSPEDALE SAN RAFFAELE

•1\. Multiple myeloma patients with early relapse after intensive front\-line treatment and disease measurable by serum biomarkers that have obtained at least a VGPR after second\-line salvage treatment;
•2\. Able and willing to provide written informed consent;
•3\. Able to comply with study protocol and procedures;
•4\. Male or Female;
•5\. Age 18\-70 years;
•6\. Fit patients: Performance status scores: ECOG \<2 and Karnofsky \> 70%; Life expectancy of \= 6 months;
•7\. Adequate cardiac, renal, hepatic and pulmonary functions;
•8\. Women of child\-bearing potential enrolled in the study must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial;
•9\. Men enrolled in the study with partners who are women of child bearing potential, must be willing to use an acceptable barrier contraceptive method during the trial or have undergone successful vasectomy at least 6 months prior to entry into the study.
•Are the trial subjects under 18? no

•1\. Use of other investigational agents within 4 weeks prior to experimental treatment (within 6 weeks if use of long\-acting agents);
•2\. Severe active viral, bacterial, or fungal infection at eligibility evaluation;
•3\. Active autoimmune disease or a history of clinically relevant autoimmune manifestations requiring immunosuppressive treatment, i.e. psoriasis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, immune\-mediated peripheral neuropathies;
•4\. Sarcoidosis requiring active steroid or immunosuppressive treatment;
•5\. Primary amyloidosis;
•6\. History of neuropsychiatric illness including severe depression, schizophrenia, bipolar disorders, impaired cognitive function, dementia or suicidal tendency;
•7\. Neuropathy \> grade 2;
•8\. History of severe cardiovascular disease such as prior stroke, coronary artery disease requiring intervention, unresolved arrhythmias;
•9\. Malignant neoplasia (except local skin cancer or cervical intraepithelial neoplasia) or family history of familial cancer syndromes;
•10\. Myelodysplasia, cytogenetic or molecular alterations specifically associated with clonal hematopoiesis of the myeloid lineage, or other serious hematological disorder other than the plasma cell dyscrasia;