Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma

NCT06105554 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2023-0527NCI-2023-09082
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (2)

Phase 1 (dose escalation)

EXPERIMENTAL

Phase 1, the dose of belumosudil mesylate participants receive will depend on when participants join this study. The first group of participants will receive the lowest dose level of belumosudil mesylate.

Drug: Belumosudil mesylate

Phase 2 (dose expansion)

EXPERIMENTAL

Phase 2, participants will receive belumosudil mesylate at the recommended dose that was found in Phase 1.

Drug: Belumosudil mesylate

Interventions

Belumosudil mesylate DRUG

Given by PO

Phase 1 (dose escalation); Phase 2 (dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 subjects 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 whole-body low dose computed tomography (WB-LDCT); 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 ≥10% but must still meet the criteria for evidence of end-organ damage.
• 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

You may not qualify if:

• 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 administered more than 2 weeks earlier have not recovered to a severity of grade 0 or grade 1, or to their pre-treatment baseline.
• 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 from comorbid medical conditions.
• 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. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• 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 psychiatric illness/social situations that would limit compliance with study requirements, in the opinion of the Principal Investigator.
• 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, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant, or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• 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 with female partners who could potentially become pregnant, will not be excluded but will be required to pursue contraceptive methods.
• 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 from prior malignancies for \>5 years, and are considered by their physician to be at less than 30% risk of relapse. Finally, patients who are on hormonal therapy for a history of either prostate cancer or breast cancer may enroll, provided that there has been no evidence of disease progression during the previous three years.
• 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, endocrinopathy, monoclonal protein, and skin changes).
• Patients who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with belumosudil.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi US Services, Inc: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert Orlowski, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Orlowski, M D

CONTACT

(713) 794-3234; rorlowski@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)