Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07025005

Clinical Study to Evaluate the Role of Fenofibrate in Preventing Peripheral Neuropathy Caused by Bortezomib, Lenalidomide, and Dexamethasone (VRd) in Multiple Myeloma Patients

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

44

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

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

Eligible

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
Not Eligible

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)

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 2 locations

1

Damanhur Oncology Center

Damanhur, El- Behira, Egypt

Actively Recruiting

2

Tanta University

Tanta, El-Gharbya, Egypt

Actively Recruiting

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Research Team

A

Ashraf M Alaa, BSc of clinical pharmacy

S

Sahar M El-Haggar, Professor of Clinical Pharmacy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Bortezomib-induced peripheral neuropathy is related to altered levels of brain-derived neurotrophic factor in the peripheral blood of patients with multiple myeloma.

David Azoulay, David Lavie, Netanel Horowitz...

https://pubmed.ncbi.nlm.nih.gov/24164472

Targeting Peroxisome Proliferator-Activated Receptor-α (PPAR- α) to reduce paclitaxel-induced peripheral neuropathy.

Martial Caillaud, Nipa H Patel, Alyssa White...

https://pubmed.ncbi.nlm.nih.gov/33434562