Early Phase 1 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years.
• People who are well enough to carry out normal daily activities or light physical work (this is measured by a standard performance scale called ECOG, with a score of 0 or 1).
• People whose doctors expect them to live for at least 12 weeks.
• People who have a confirmed diagnosis of multiple myeloma (a blood cancer affecting plasma cells) based on internationally recognised criteria, OR a confirmed diagnosis of an aggressive type of B-cell non-Hodgkin lymphoma (a cancer of the lymphatic system), including specific subtypes such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma with certain gene changes, primary mediastinal B-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, or large B-cell lymphoma that has transformed from a slower-growing lymphoma.
• For multiple myeloma patients only: People who have already received at least 2 separate rounds of cancer treatment, with each round lasting at least one full cycle, and whose cancer has come back or continued to grow during or within 12 months of their last treatment — OR people whose cancer no longer responds to two specific types of medicines (immunomodulators and proteasome inhibitors) and did not improve or got worse within 60 days of finishing their last treatment.
• For multiple myeloma patients only: People who have signs of measurable disease at the screening stage, such as detectable levels of specific abnormal proteins in the blood or urine, abnormal light chain levels in the blood, a high percentage of abnormal plasma cells in the bone marrow, or at least one tumour outside the bone marrow that is at least 2 cm in size.
• For aggressive B-cell lymphoma patients only: People who have received at least 2 separate rounds of cancer treatment and whose cancer did not respond to or came back after their most recent treatment (which must have included standard medicines containing anti-CD20 antibodies, unless the tumour does not have CD20, and anthracycline-based chemotherapy).
• For aggressive B-cell lymphoma patients only: People who have at least one measurable area of cancer at the screening stage — lymph node tumours must be larger than 1.5 cm, and tumours outside lymph nodes must be larger than 1.0 cm.
• People whose blood counts meet minimum levels — including haemoglobin (a measure of red blood cells), neutrophils (infection-fighting white blood cells), platelets (cells that help blood clot), and lymphocytes (another type of immune cell) — without having had certain blood-boosting injections shortly before the blood test.
• People whose kidneys are functioning at an adequate level (confirm with trial site for multiple myeloma patients with lower kidney function, as exceptions may apply).
• People whose liver function tests are within acceptable ranges (with some flexibility for people with a condition called Gilbert's syndrome or those whose liver is affected by their cancer).
• People whose heart is pumping blood effectively enough, as measured by a heart scan (left ventricular ejection fraction of at least 45%).
• People whose blood oxygen levels are at least 92% without needing supplemental oxygen.
• Women who could become pregnant must have a negative blood pregnancy test and must not be breastfeeding at the time of joining the trial.
• People who could father or become pregnant must agree to use effective contraception from the time of signing the consent form until 1 year after receiving the trial treatment.
• People who could father or become pregnant must agree not to donate sperm or eggs from the time of signing the consent form until 1 year after receiving the trial treatment.
• People (or their legal representative) who give written informed consent, showing they understand the purpose and procedures of the trial and are willing to take part.

Who may not be able to join:

• People who have recently received certain types of cancer or investigational treatments within specific timeframes before joining — including targeted therapies, experimental drugs or devices, immunosuppressant medicines, monoclonal antibodies, chemotherapy, proteasome inhibitors, immunomodulators, high-dose steroids, or radiotherapy covering a large portion of the bone marrow (different waiting periods apply to each type — confirm with trial site).
• People who had an autologous stem cell transplant (using their own stem cells) within the past 24 weeks.
• People who have ever had an organ transplant or a stem cell transplant using someone else's stem cells.
• People who have had another type of cancer, unless it was fully treated with no signs of active disease in the past 2 years, or was a type of skin cancer (not melanoma) that was adequately treated with no current signs of disease.
• People who have previously been treated with a specific type of experimental viral therapy using a vesicular stomatitis virus G (VSVG)-based approach (confirm with trial site).
• People whose cancer has spread to the brain or spinal fluid, or who have symptoms suggesting this.
• People with a serious, currently active infection (such as a bacterial, viral, or fungal infection) that is not well controlled.
• People with an active autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) or any condition that requires ongoing treatment with medicines that suppress the immune system.
• People with inherited bleeding or clotting disorders, or other conditions that may increase the risk of bleeding.
• People who have had an active deep vein thrombosis (blood clot in a vein) or pulmonary embolism (blood clot in the lungs) within the past 12 weeks — unless a doctor has determined the clot has been adequately treated and poses no risk of breaking off.
• People who test positive for hepatitis B with detectable virus levels in the blood, or who test positive for hepatitis C with detectable virus levels in the blood, or who test positive for HIV, or who test positive for syphilis.
• People with significant heart problems, including: moderate to severe heart failure (NYHA class III or IV); a heart attack, heart bypass surgery, or coronary stent placement within the past 24 weeks; a significant irregular heartbeat or unexplained fainting (unless caused by dehydration or a simple fainting response); or a history of significant non-ischemic heart muscle disease.
• People with certain other significant medical conditions, including: a primary immune system deficiency; a stroke or seizure within the past 24 weeks; clear signs of dementia or significant mental status changes; or a history of Parkinson's disease or similar movement disorders.
• People who had surgery within the 2 weeks before joining, or who plan to have surgery (other than under local anaesthetic) within 2 weeks after receiving the trial treatment.
• People who received a live-attenuated or inactivated vaccine within the 28 days before joining.
• People with a known severe allergic reaction to the trial drug (OriV508) or any of its ingredients.
• People with a known severe allergic reaction to a medicine called tocilizumab.
• People in whom a suitable vein cannot be accessed for treatment.
• People who the trial doctor considers unsuitable for any other reason.

Important: Always verify eligibility with the trial site directly before applying.