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New treatment option for Multiple Myeloma
Official title Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06105554
What this study is testing
What is Belumosudil mesylate?
Belumosudil mesylate is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1 is to find the recommended dose of belumosudil mesylate that can be given to patients with relapsed/refractory MM. Phase 2 is to learn if the dose of belumosudil mesylate found in Phase 1 can help to control the disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have had a histologically or cytologically confirmed diagnosis of symptomatic multiple myeloma at the time of their initial diagnosis...
- Clonal bone marrow plasma cells ≥10%, AND
- A monoclonal protein in either the serum or urine (except in people with non-secretory myeloma), AND
- Evidence of end-organ damage or a myeloma-defining event that can be attributed to the underlying plasma cell proliferative disorder (to include one...
- Hypercalcemia (corrected calcium \>2.75 mmol/L or 11.5 mg/dL); OR
You likely can't join if
- Patients who are receiving any concurrent investigational agent with known or suspected activity against multiple myeloma, or those whose adverse...
- Patients who have an ECOG \>2 will be excluded from this clinical trial because of their poor functional status which could confound the evaluation...
- Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to belumosudil mesylate.
- Patients with known clinically active hepatitis A, B, and/or C infection, due to the difficulty that would be faced in assessing the attribution of...
- Uncontrolled intercurrent illness including not related to multiple myeloma, but not limited to, ongoing or active infection, symptomatic congestive...
- The effects of belumosudil mesylate on the developing human fetus are unknown, and women of child-bearing potential and men must therefore agree to...
See the full eligibility criteria
Who can join
- Patients must have had a histologically or cytologically confirmed diagnosis of symptomatic multiple myeloma at the time of their initial diagnosis, which requires the presence of all three of the following criteria:
- Clonal bone marrow plasma cells ≥10%, AND
- A monoclonal protein in either the serum or urine (except in people with non-secretory myeloma), AND
- Evidence of end-organ damage or a myeloma-defining event that can be attributed to the underlying plasma cell proliferative disorder (to include one or more of the following):
- Hypercalcemia (corrected calcium \>2.75 mmol/L or 11.5 mg/dL); OR
- Renal insufficiency attributable to myeloma (serum creatinine \> 1.9 mg/dL); OR
- Anemia; normochromic, normocytic with a hemoglobin value ≥2 g/dL below the lower limit of normal, or a hemoglobin or \<10 g/dL; OR
- Bone lytic lesions, severe osteopenia or pathologic fractures detected on a radiographic boney survey, OR
- More than 1 myeloma-related lesion on advanced imaging, including either by magnetic resonance imaging (MRI), whole-body MRI (WB-MRI), positron emission tomography with embedded computed tomography (PET/CT), or...
- Clonal bone marrow plasma cells ≥60%; OR
- Involved/uninvolved serum free light chain ratio of 100 or more
- Patients with a biopsy-proven plasmacytoma and either a serum or urine monoclonal protein will also be considered to have met the diagnostic criteria for multiple myeloma in the absence of clonal marrow plasmacytosis of...
- Patients must have measurable disease, as defined by at least one of the following:
- Serum monoclonal protein level ≥0.5 g/dL for IgG, IgA, or IgM disease
- Monoclonal protein or total serum IgD or IgE above the upper limit of normal for IgD or IgE disease
- Urinary M-protein excretion of ≥200 mg over a 24-hour period if the serum monoclonal protein does not meet the above criteria
- Involved free light chain level ≥10 mg/dL, along with an abnormal free light chain ratio, if the serum monoclonal protein and urinary monoclonal protein do not meet the above criteria
- Bone marrow involvement of at least 30% if none of the above criteria are met
- Patients must have measurable refractory/relapsed multiple myeloma for which they have received three (3) or more prior lines of therapy with triple class (proteasome inhibitor (PI), immunomodulatory drug (IMiD), and...
- Patients must be age 18 or older, must be willing and able to provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 (Appendix 13.5), unless the performance status is 3 due to disease burden or disease-related symptoms, such as pain.
- Patients must have evidence of adequate bone marrow reserves, as defined by the following:
- Absolute neutrophil count (ANC) ≥1,000 cells/mm3 without growth factor support within 1 week of the initiation of treatment
- Total white blood cell count (WBC) ≥2,000 cells/mm3 without growth factor support within 1 week of the initiation of treatment
- Hemoglobin ≥8 g/dL without red blood cell transfusions within 2 weeks of the initiation of treatment
- Platelet count of ≥50,000 cells/mm3
- Patients must have evidence of adequate hepatic function, as defined by the following:
- Total bilirubin ≤2.5 times the institutional upper limit of the normal values (IULN), except for patients that have previously suspected Gilbert's disease
- Total aspartate aminotransferase (AST (SGOT)) and alanine aminotransferase (ALT (SGPT)) ≤2.5 times the IULN
- Patients must have evidence of adequate cardiac function, as defined by the following:
- Absence of New York Heart Association (NYHA) class II, III, or IV congestive heart failure (Appendix 13.6)
- Absence of uncontrolled angina or hypertension
- Absence of myocardial infarction in the previous 6 months
- Absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia, defined as grade 3 or 4 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)...
- Corrected QT interval (QTc) \<480 milliseconds using Fridericia's QT correction formula (QTc = QT / RR1/3)
- Patients must have evidence of adequate renal function, as defined by the following:
- Serum creatinine within the institutional normal limits, OR if the creatinine is elevated
- Creatinine clearance (CrCl) ≥30 mL/min., as measured by a 24-hour urine collection, or estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (CKD-EPI) equation (43) as follows:
- eGFRcr = 142 x min(Scr/κ, 1)α x max(Scr/κ, 1)-1.200 x 0.9938Age x 1.012 [if female], where:
- Scr = standardized serum creatinine in mg/dL
- κ = 0.7 (females) or 0.9 (males)
- α = -0.241 (female) or -0.302 (male)
- min(Scr/κ, 1) is the minimum of Scr/κ or 1.0
- max(Scr/κ, 1) is the maximum of Scr/κ or 1.0
- Age (years)
- HIV seropositive patients with acceptable organ function who meet the patient selection criteria, and who are not on combination anti-retroviral therapy, and who have an absolute CD4+ count \>1,000 cells/mm3 of blood...
- Male patients must agree to use an adequate method of contraception for the duration of the study since the effects of belumosudil mesylate on the developing human fetus are unknown. Female patients must be either...
What rules you out
- Patients who are receiving any concurrent investigational agent with known or suspected activity against multiple myeloma, or those whose adverse events due to chemotherapeutic/ immunologic agents or radiation therapy...
- Patients who have an ECOG \>2 will be excluded from this clinical trial because of their poor functional status which could confound the evaluation of adverse events unless this is felt to be disease-related and not...
- Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to belumosudil mesylate.
- Patients with known clinically active hepatitis A, B, and/or C infection, due to the difficulty that would be faced in assessing the attribution of any events of hepatic toxicity while on belumosudil mesylate therapy...
- Uncontrolled intercurrent illness including not related to multiple myeloma, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or...
- The effects of belumosudil mesylate on the developing human fetus are unknown, and women of child-bearing potential and men must therefore agree to use adequate contraception (hormonal or barrier method of birth...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (follicle stimulating hormone and estradiol in menopausal range, or women who have received whole pelvic radiation therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of belumosudil mesylate administration.
- Pregnant or lactating women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with belumosudil mesylate. Male patients...
- Patients with a "currently active" second malignancy should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free...
- Patients with active plasma cell leukemia, defined as having ≥5% of peripheral white blood cells comprised of CD138+ plasma cells (44), or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly...
- Patients who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with belumosudil.
- Patients who are HIV positive and on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with belumosudil mesylate. However, HIV seropositive patients with...
- Patients who have known and currently active central nervous system involvement with multiple myeloma will be excluded from this clinical trial because of their poor prognosis, and because they often develop progressive...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.