What is Fenofibrate studying for peripheral neuropathy in multiple myeloma?

Fenofibrate is being studied to see if it can reduce nerve damage caused by the VRd chemotherapy regimen in newly diagnosed multiple myeloma patients. The trial compares nerve health and biological markers between patients receiving VRd with and without Fenofibrate. This research is sponsored by Tanta University to explore ways to lessen treatment side effects.

Who may be eligible for this multiple myeloma clinical trial?

Adults aged 18 and older with newly diagnosed multiple myeloma who are starting treatment with the VRd chemotherapy regimen may qualify. Both men and women can participate, but they must have good overall health and no prior recent use of neurotoxic drugs. Please review eligibility criteria for more details.

Is there any cost to participate in this multiple myeloma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07025005

Study of Fenofibrate to Prevent Peripheral Neuropathy in Multiple Myeloma Patients Treated with Bortezomib, Lenalidomide, and Dexamethasone VRd

Led by Tanta University · Updated on 2025-11-04

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the possible role of Fenofibrate in reducing peripheral neuropathy caused by the VRd regimen, which includes bortezomib, lenalidomide, and dexamethasone, in patients newly diagnosed with multiple myeloma. This study focuses on assessing neuropathy using standardized grading scales and questionnaires, along with biological markers such as Brain-derived neurotrophic factor BDNF and Neuro-filament light chain NfL. The trial compares two groups of patients receiving VRd treatment, one with Fenofibrate added and one without. Participants are randomly assigned to one of two groups the Fenofibrate group receives 6 cycles of the VRd regimen plus Fenofibrate 160 mg orally once daily during the treatment cycles the control group receives only the 6 cycles of the VRd regimen every 28 days. Bortezomib is given subcutaneously at specific days in each cycle, lenalidomide is taken orally for 21 days, and dexamethasone is administered orally on four days per cycle. The study interventions last through the 6 cycles of VRd treatment. During the trial, neuropathy severity is evaluated at baseline and after every two VRd cycles using the NCI-CTCAE criteria and a neurotoxicity questionnaire. Blood samples are collected to measure BDNF and NfL levels at the start and within one week after the final VRd cycle. Researchers monitor changes in neuropathy grades, questionnaire scores, and biological markers to understand the impact of Fenofibrate. Participants are followed throughout the treatment period, which lasts approximately six months.

CONDITIONS

Brief Title

Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone (VRd) Protocol in the Treatment of Patients With Multiple Myeloma (MM)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Newly diagnosed multiple myeloma according to International Myeloma Working Group criteria
Currently treated with bortezomib-based VRd chemotherapy regimen
Performance status less than 2 by Eastern Cooperative Oncology Group (ECOG) score
Adequate blood counts: neutrophils ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 10 g/dl
Adequate liver function: serum bilirubin < 1.2 mg/dl
Adequate kidney function: serum creatinine < 1.5 mg/dl

You will not qualify if you...

Prior use of neurotoxic agents (e.g., cis-platin, vincristine, taxanes) within 6 months
Use of antioxidant vitamins, anticonvulsants, tricyclic antidepressants, or neuropathic pain medications
Preexisting peripheral neuropathy from diabetes, brain disorders, hypothyroidism, autoimmune diseases, hepatitis C
Presence of inflammatory diseases such as ulcerative colitis or rheumatoid arthritis
Conditions linked to oxidative stress like smoking, tuberculosis, or obesity
Active liver disease including cirrhosis, fatty liver, hepatitis C
Myopathy or other malignancies
Renal impairment including end-stage renal disease or dialysis
Gallbladder disease or gallstones
Pregnant or breastfeeding women
Known allergy to fenofibrates
Concurrent use of certain drugs that may interact with fenofibrate (e.g., statins, colchicine, ciprofibrate, enzyme inducers or inhibitors, drugs with high plasma protein binding)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 cycles of 28 days each

Participants receive 6 cycles of the bortezomib, lenalidomide, and dexamethasone (VRd) regimen. Some participants also take fenofibrate 160 mg tablets once daily during these 6 cycles to evaluate its role in preventing peripheral neuropathy.

Visits at the start of each cycle and assessments every 2 cycles during treatment