Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 who were diagnosed with multiple myeloma confirmed by a tissue or cell sample, where the diagnosis included abnormal plasma cells making up at least 10% of bone marrow cells, an abnormal protein in the blood or urine, and signs of organ damage or other specific disease markers (such as high calcium levels, reduced kidney function, low red blood cell counts, bone damage, or certain abnormal scan results).
• People with a biopsy-confirmed tumour outside the bone marrow (plasmacytoma) and an abnormal protein in the blood or urine, even without the 10% bone marrow threshold, provided there is still evidence of organ damage.
• People whose myeloma can be measured through specific blood, urine, or bone marrow tests that show the disease is still active and detectable.
• People whose myeloma has returned or stopped responding to treatment, and who have already received three or more prior treatment regimens — including treatments from three specific drug classes (proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies) — or who have received two of these drug classes and cannot tolerate the third due to side effects such as nerve damage, drug allergies, or serious reactions.
• People who have finished radiation therapy or steroid treatment at least two weeks before starting the trial drug.
• People aged 18 or older who are able and willing to give written consent to participate, and who understand they may withdraw at any time without affecting their ongoing care.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (ECOG), or rated as 3 only if the reduced function is caused directly by the myeloma rather than other health conditions.
• People whose blood test results show the bone marrow is producing enough blood cells — including sufficient white blood cells, red blood cells, and platelets — without needing recent transfusions or growth factor support.
• People whose liver function tests fall within acceptable ranges as defined by the trial.
• People with adequate heart function, including no significant heart failure, no uncontrolled chest pain or high blood pressure, no heart attack in the past six months, no serious irregular heartbeat, and a normal heart electrical measurement (QTc below 480 milliseconds).
• People whose kidneys are working well enough, either with a normal creatinine blood level or a kidney filtration rate of at least 30 mL/min as calculated by a urine test or standard formula.
• People who are HIV-positive with a good immune cell count (CD4+ above 1,000 cells/mm³), acceptable organ function, and who are not currently on combination anti-retroviral therapy.
• Male participants who agree to use an effective method of contraception for the duration of the trial.
• Female participants who are either post-menopausal, have had a surgical procedure that prevents pregnancy, or who agree to use two effective methods of contraception or abstain from heterosexual activity for the duration of the trial.
• Female participants of childbearing potential who have a negative pregnancy test before starting the trial drug.

Who may not be able to join:

• People currently taking another experimental treatment aimed at multiple myeloma, or those who still have significant side effects (above a mild level) from prior chemotherapy, immunotherapy, or radiation given more than two weeks ago.
• People with a general health rating above 2 on the ECOG scale, unless the reduced function is clearly caused by myeloma itself rather than other medical conditions.
• People with a known history of allergic reactions to drugs that are chemically or biologically similar to the trial drug (belumosudil mesylate).
• People with a currently active hepatitis A, B, or C infection — though people with chronic hepatitis B whose viral levels are undetectable on treatment, or people previously treated and cured of hepatitis C, may still be considered (confirm with trial site).
• People with other serious uncontrolled illnesses unrelated to myeloma, such as active infections, uncontrolled heart problems, or significant mental health or social circumstances that could affect their ability to follow the study requirements.
• Women who could become pregnant and who are not willing or able to use effective contraception during the trial — unless they meet specific criteria such as being post-menopausal, having had a hysterectomy, both ovaries removed, both fallopian tubes tied or removed, ovarian failure, or another surgical sterilisation procedure.
• Pregnant or breastfeeding women, due to unknown but potential risks to the infant from the trial drug.
• Male participants whose female partners could become pregnant, who are not willing to use contraception during the trial and for four months after finishing the trial drug.
• People with another cancer that is currently active — though people who finished treatment for a prior cancer, have been disease-free for more than five years, and whose doctor considers relapse risk to be below 30%, may still be considered. People on hormonal therapy for a history of prostate or breast cancer with no sign of disease progression in the past three years may also be considered (confirm with trial site).
• People with active plasma cell leukaemia (a specific advanced form of plasma cell disease) or a condition called POEMS syndrome.
• People who have had a plasmapheresis (a blood-filtering procedure) within two weeks before starting the trial drug.
• People who are HIV-positive and currently on combination anti-retroviral therapy, due to potential interactions with the trial drug.
• People with known and currently active spread of myeloma into the central nervous system (brain or spinal cord).

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