Phase 2 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 80 years (inclusive) at the time of signing the consent form
• People newly diagnosed with primary plasma cell leukemia (a rare and aggressive blood cancer), confirmed according to current international diagnostic standards, including a certain percentage of abnormal plasma cells detected in the blood and/or bone marrow
• People whose disease can be measured through specific blood or urine protein tests, confirming there is enough detectable disease to track during the trial
• People whose treatment plan includes high-dose therapy, with or without a stem cell transplant
• People who have not yet received any systemic (whole-body) treatment or stem cell transplant for their plasma cell condition, except for a short course of steroid medication (such as a low-dose dexamethasone course of up to 4 days)
• People whose bone marrow is functioning at an adequate level, based on blood counts for red blood cells, white blood cells, and platelets (with some support treatments permitted)
• People whose liver is functioning at an adequate level, based on standard blood tests
• People whose kidneys are functioning at an adequate level, with a kidney filtration rate of at least 20 mL/min
• People with a general health and functioning level rated 0 to 3 on a standard oncology scale (ranging from fully active to capable of limited self-care)
• Women who could potentially become pregnant must agree to use two reliable forms of contraception or remain abstinent throughout the trial and for 3 months after the last dose, agree not to donate eggs during this period, and have two negative pregnancy tests before starting treatment
• Men who are sexually active with women who could potentially become pregnant must agree to use a condom throughout the trial and for 3 months after the last dose, and must not donate sperm during this period
• People who are able to understand and willing to follow the trial requirements
• People who are able to understand and willing to provide written consent before any trial-related procedures begin

Who may not be able to join:

• People with secondary plasma cell leukemia (a form that develops from a pre-existing condition rather than arising on its own)
• People who have had another invasive cancer within the past 5 years, with some exceptions for cancers that were fully treated and have shown no signs of returning for at least 3 years, or certain low-risk skin or localised cancers considered cured
• People who have had radiation therapy within 14 days before the planned start of treatment
• People who have undergone a plasma-filtering procedure (plasmapheresis) within 28 days before the planned start of treatment
• People showing signs that the disease has spread to the brain or spinal fluid
• People experiencing nerve damage or nerve-related pain rated at a moderate level or higher (Grade 2 or above on a standard medical scale)
• People with certain other serious medical conditions, including a related protein-deposit disease (amyloidosis), a specific syndrome called POEMS, active serious infections, uncontrolled diabetes, severe lung conditions, or other conditions that in the trial doctor's judgment would make participation unsafe or interfere with results
• People with a known chronic lung condition (COPD) where breathing capacity is below 50% of the expected normal level
• People with moderate or severe persistent asthma in the past 2 years, or currently uncontrolled asthma of any type
• People who test positive for HIV, hepatitis B, or hepatitis C
• People with significant heart conditions, including a heart attack within the past 6 months, unstable or poorly controlled heart disease, inflammation around the heart, protein deposits in the heart, uncontrolled irregular heart rhythms, an abnormal heart electrical reading above a certain threshold, or a significantly reduced heart pumping function (the pumping function test is required only for people aged 65 or older)
• People who have recently taken a medication that strongly affects how the body processes certain drugs (a strong CYP3A4 inducer), within a defined period before starting treatment
• People with known allergies or sensitivities to any of the key ingredients in the study medications, including boron, mannitol, steroids, monoclonal antibodies, or related substances
• People with a digestive condition that may significantly affect how oral medications are absorbed, as judged by the trial doctor
• People who have received a live vaccine within 4 weeks before the planned start of treatment
• People who have had major surgery within 2 weeks before the planned start of treatment, have not fully recovered from surgery, or have surgery planned around the time treatment is expected to begin
• People currently receiving other cancer treatments
• People who, in the trial doctor's opinion, may not be able to follow the study requirements, or whose participation would not be in their best interest
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 3 months after the last dose
• Men who plan to father a child during the trial or within 3 months after the last dose
• People currently taking part in another clinical trial or who have received an experimental treatment within 30 days or 5 half-lives (whichever is longer) before the screening visit
• People for whom any of the study medications — daratumumab, bortezomib, dexamethasone, cyclophosphamide, or doxorubicin — are specifically contraindicated according to local prescribing guidelines

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