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:

For people with relapsed or refractory multiple myeloma:

• People who have an official diagnosis of multiple myeloma based on recognised international diagnostic guidelines
• People whose myeloma has come back or stopped responding to treatment, and who have previously been treated with at least three specific types of therapy (a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 therapy) — the exact number of prior treatment lines required varies depending on which part of the trial applies (confirm with trial site)
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health performance scale (ECOG score of 0 or 1)
• People whose disease can be detected and measured through blood, urine, or imaging tests at the time of screening, according to specific laboratory thresholds (confirm with trial site for exact values)

For people with previously treated AL amyloidosis:

• People who have a confirmed tissue-based diagnosis of amyloidosis
• People who are not considered suitable candidates for currently available AL amyloidosis treatments with known clinical benefit, and who have received a minimum number of prior treatment cycles (at least 3 cycles of one prior treatment line, or at least 2 cycles each of two or more prior treatment lines)
• People whose disease is measurable at screening through specific blood or protein tests meeting defined thresholds (confirm with trial site for exact values)
• People who have one or more organs affected by AL amyloidosis
• People whose heart is pumping with at least 45% efficiency, as measured by a standard heart function test

Who may not be able to join:

For people with relapsed or refractory multiple myeloma:

• People whose myeloma has spread to the brain or the fluid surrounding the brain and spinal cord
• People who have certain related blood or plasma cell conditions, including active plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis
• People who have received a high cumulative dose of steroid medication (equivalent to more than 140 mg of prednisone) in the 14 days before treatment would begin
• People who have received certain prior cancer treatments too recently before the start of the trial, including some targeted therapies, radiation, gene-modified cell therapies, or T-cell redirecting therapies — each has a different required waiting period (confirm with trial site)
• People who have had an allogeneic (donor) stem cell transplant within the past 6 months, or an autologous (own cells) transplant within the past 12 weeks
• People who have received a live attenuated vaccine within 4 weeks before the first dose
• People who still have significant side effects from previous cancer treatment that have not returned to near-normal levels (with some exceptions, such as hair loss or certain nerve-related side effects)
• People with certain serious medical conditions, including breathing problems requiring supplemental oxygen, HIV, active hepatitis B or C, a stroke or seizure within the past 6 months, active autoimmune disease, active serious infections, or significant heart conditions such as a recent heart attack or advanced heart failure
• People in one specific part of the trial (Part 2C) whose disease progressed or stopped responding after CAR-T cell therapy

For people with previously treated AL amyloidosis:

• People whose amyloidosis has spread to the brain or the fluid surrounding the brain and spinal cord
• People who have any form of amyloidosis other than AL amyloidosis (for example, ATTR amyloidosis)
• People who have active plasma cell leukaemia, Waldenström's macroglobulinaemia, or POEMS syndrome
• People who require supplemental oxygen due to breathing difficulties
• People with serious active infections, active autoimmune disease, HIV, active hepatitis B or C, a stroke or seizure within the past 6 months, or significant heart conditions
• People who have a current or past diagnosis of symptomatic multiple myeloma
• People who have severe tongue enlargement that causes difficulty swallowing
• People who have received a high cumulative dose of steroid medication (equivalent to more than 140 mg of prednisone) in the 14 days before treatment would begin
• People who have received certain prior cancer treatments too recently before the start of the trial, with specific waiting periods depending on the type of treatment (confirm with trial site)
• People who have had an allogeneic (donor) stem cell transplant within the past 6 months, or an autologous (own cells) transplant within the past 12 weeks
• People who have received a live attenuated vaccine within 4 weeks before the first dose
• People who still have significant side effects from previous cancer treatment that have not returned to near-normal levels (with some exceptions, such as hair loss or certain nerve-related side effects)

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