Peripheral NeuropathyPhase 4VRd MM FibrateNCT07025005
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)
A Phase 4 study testing Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet and Bortezomib + Lenalidomide + Dexamethasone in people with Peripheral Neuropathy and Multiple Myeloma, Neoplasms, run by Tanta University at 2 sites in Egypt.
Trial summary
This study aims at evaluating the possible beneficial role of Fenofibrate in attenuating the peripheral neuropathy associated with bortezomib (velcade), lenalidomide (revlimid), and dexamethasone (VRd) regimen in newly diagnosed multiple myeloma patients.The study aims to asses VRd protocol induced peripheral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Multiple Myeloma, Neoplasms
- What is being tested?
- Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet and Bortezomib + Lenalidomide + Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Aug 2025to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Newly diagnosed MM patients according to the revised International Myeloma Working Group Diagnostic Criteria for the diagnosis of Multiple Myeloma (IMWG).
- Patients being treated by bortezomib-based VRd chemotherapy regimen.
- Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.
- Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
- Patients with adequate liver function (serum bilirubin < 1.2 mg/dl) and adequate renal function (serum creatinine < 1.5 mg/d).
Who cannot join
- Patients with prior exposure to neurotoxic agents (Cis-platin, vincristine, taxanes, foscarnet, INH, etc..) in the last 6 months.
- Concomitant use of antioxidant vitamins (vitamin A, C, E), anticonvulsants, tricyclic antidepressants, other medications used for neuropathic pain (gabapentin, lamotrigine, carbamazepine).
- Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.
- Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).
- Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity).
- Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..).
Show all 13Show fewer
- Patients with myopathy.
- Patients with other malignancies.
- Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis.
- Patients with Gallbladder disease and gallstones.
- Pregnant and breast-feeding women.
- Patients with Known allergy to the fenofibrates.
- Concurrent use of statin, colchicine, Ciprofibrate, idelalisib, enzyme inducers (phenytoin, phenobarbitone, carbamazepine,…), enzyme inhibitors (ketoconazole, clarithromycin,…), drugs with high plasma protein binding capacity (Sulfonamides, valproate, oral hypoglycemic, warfarin,…) to avoid potential pharmacodynamics and pharmacokinetic drug interactions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sahar M El-Haggar, Professor of Clinical Pharmacy contact
Egypt2 sites, 2 recruiting
- Recruiting
Damanhur Oncology Center
Damanhur, El- Behira
- Recruiting
Tanta University
Tanta, El-Gharbya
About this study
Official title: Clinical Study to Evaluate the Possible Role of Fenofibrate in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone Protocol in the Treatment of Patients With Multiple Myeloma
This study aims at evaluating the possible beneficial role of Fenofibrate in attenuating the peripheral neuropathy associated with bortezomib (velcade), lenalidomide (revlimid), and dexamethasone (VRd) regimen in newly diagnosed multiple myeloma patients.The study aims to asses VRd protocol induced peripheral neuropathy through:
- The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) and The use of Neurotoxicity-12 items questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12 for grading of neuropathy at baseline and by the end of every two VRd cycles.
- The assessment of biological markers:
Read more
Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL). through comparing two groups: Group one: (Control group; n=22): which will receive 6 cycles of VRd regimen (each cycle will be given every 28 days).
Group two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.
Read the detailed description
Multiple myeloma is considered an incurable disease so several regimens are available for the management of multiple myeloma.
Among these regimens there is the bortezomib, lenalidomide and dexamethasone (RVd or VRd) regimen which is the preferred induction regimen for most patients with newly diagnosed multiple myeloma (NDMM).
Bortezomib has hematologic and non-hematologic adverse reactions. From the non-hematologic adverse reactions there is the bortezomib-induced peripheral neuropathy (BIPN) that remains the most intractable common adverse reactions that occur during bortezomib treatment with no recommended therapies available for preventing or treating existing BIPN.
Fenofibrate a peroxisome proliferator-activated receptor-alpha (PPARα) agonist that is widely used in the management of hypercholesterolemia and hypertriglyceridemia has been proposed as a key lipid metabolism modulator and regulator of inflammation.
Preclinical studies showed that treatment with fenofibrate partially reversed and prevented the development of mechanical and cold hypersensitivity induced by paclitaxel through the regulation of peroxisome proliferator-activated receptor-alpha (PPAR-α) expression and decrease neuroinflammation in the dorsal root ganglia (DRG) without decreasing the antitumoral effect of paclitaxel.
- Conditions
- Peripheral Neuropathy, Multiple Myeloma, Neoplasms
- Being tested
- Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet, Bortezomib + Lenalidomide + Dexamethasone
- Keywords
- peripheral neuropathy, multiple myeloma, bortezomib induced peripheral neuropathy (BIPN), Fenofibrate, VRd protocol, lenalidomide
- Medical subject headings
- Peripheral Nervous System Diseases, Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tabletDrug
Bortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22.
Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22. Fenofibrate 160 mg tablets orally once daily during the period of the 6 cycles of the(VRd) regimen.
Bortezomib + Lenalidomide + DexamethasoneDrug
Bortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22.
Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22.
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate group | Active comparator | 22 participants will receive 6 cycles of (VRd) regimen plus Fenofibrate 160 mg tablet once daily during the period of the 6 cycles. Receives: Drug: Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet |
| Control group | Other | 22 participants will receive 6 cycles of VRd regimen (each cycle will be given for 28 days) Receives: Drug: Bortezomib + Lenalidomide + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in percentage of patients with peripheral neuropathy grade ≥ 2 with the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and NCI-CTCAE, v5.
The change in percentage of patients with peripheral neuropathy grade ≥ 2 using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI-CTCAE, v5) ( where the higher the score the more severity of the peripheral neuropathy) and the use of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version (FACT/GOG-NTX-12) to assess (where the higher the score, the better the Quality of life).
Measured: The use of NCI-CTCAE, Version 5, 2017 and "FACT/GOG-Ntx-12" for the grading of peripheral neuropathy will be done at the baseline and by the end of every two VRd cycles ( the duration of each cycle is 28 days) during the 6 VRd cycles duration.
Secondary outcomes (1)
The change in serum levels of the measured biological markers Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL).
The assessment of serum level of the biological markers: Brain -derived neurotrophic factor (BDNF) (in ng/ml) and Neuro-filament light chain (NfL)( in pg/ml) will be done at the baseline (before the initiation of the treatment protocol) and within 1 week after the last VRd cycle (the 6th cycle) ( the duration of each cycle is 28 days).
Measured: The assessment of serum level of the biological markers Brain -derived neurotrophic factor (ng/ml) and Neuro-filament light chain (pg/ml) will be done at the baseline and within 1 week after the 6th VRd cycle ( the duration of each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start30 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At admission, patients will be randomized through sealed envelopes method into two groups to receive either the VRd regimen or the VRd regimen plus fenofibrate 160 mg: Group one: (Control group; n=22): which will receive 6 cycles of VRd regimen (each cycle will be given every 28 days). Group two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Mohamed Alaa Mokhtar, Tanta University
- Investigators
- Ashraf M Alaa, BSc of clinical pharmacy, Principal investigator, clinical pharmacy departement - Faculty of Pharmacy - Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025005
- Sponsor's protocol ID
- 36264MS945/5/25
- Acronym
- VRd MM Fibrate
- Status last verified
- May 2025
- First submitted
- 31 May 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin L, Hua H, Ji Y, Jia Z, Peng M, Huang S. Anti-inflammatory role of fenofibrate in treating diseases. Biomol Biomed. 2023 May 1;23(3):376-391. doi: 10.17305/bb.2022.8534.
PubMed 36724021Azoulay D, Lavie D, Horowitz N, Suriu C, Gatt ME, Akria L, Perlman R, Braester A, Ben-Yehuda D. Bortezomib-induced peripheral neuropathy is related to altered levels of brain-derived neurotrophic factor in the peripheral blood of patients with multiple myeloma. Br J Haematol. 2014 Feb;164(3):454-6. doi: 10.1111/bjh.12624. Epub 2013 Oct 25. No abstract available.
PubMed 24164472Cebulla N, Schirmer D, Runau E, Flamm L, Gommersbach S, Stengel H, Zhou X, Einsele H, Reinhold AK, Rogalla von Bieberstein B, Zeller D, Rittner H, Kortum KM, Sommer C. Neurofilament light chain levels indicate acute axonal damage under bortezomib treatment. J Neurol. 2023 Jun;270(6):2997-3007. doi: 10.1007/s00415-023-11624-2. Epub 2023 Feb 18.
PubMed 36802032Caillaud M, Patel NH, White A, Wood M, Contreras KM, Toma W, Alkhlaif Y, Roberts JL, Tran TH, Jackson AB, Poklis J, Gewirtz DA, Damaj MI. Targeting Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha) to reduce paclitaxel-induced peripheral neuropathy. Brain Behav Immun. 2021 Mar;93:172-185. doi: 10.1016/j.bbi.2021.01.004. Epub 2021 Jan 9.
PubMed 33434562Esmaeili MA, Yadav S, Gupta RK, Waggoner GR, Deloach A, Calingasan NY, Beal MF, Kiaei M. Preferential PPAR-alpha activation reduces neuroinflammation, and blocks neurodegeneration in vivo. Hum Mol Genet. 2016 Jan 15;25(2):317-27. doi: 10.1093/hmg/ddv477. Epub 2015 Nov 24.
PubMed 26604138Yamamoto S, Egashira N. Pathological Mechanisms of Bortezomib-Induced Peripheral Neuropathy. Int J Mol Sci. 2021 Jan 17;22(2):888. doi: 10.3390/ijms22020888.
PubMed 33477371
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Role of Fenofibrate in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone Protocol in the Treatment of Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07025005
- Acronym / sponsor ID
- VRd MM Fibrate / 36264MS945/5/25
- Conditions
- Peripheral Neuropathy, Multiple Myeloma, Neoplasms
- Keywords
- peripheral neuropathy, multiple myeloma, bortezomib induced peripheral neuropathy (BIPN), Fenofibrate, VRd protocol, lenalidomide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at evaluating the possible beneficial role of Fenofibrate in attenuating the peripheral neuropathy associated with bortezomib (velcade), lenalidomide (revlimid), and dexamethasone (VRd) regimen in newly diagnosed multiple myeloma patients.The study aims to asses VRd protocol induced peripheral neuropathy through:
- The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) and The use of Neurotoxicity-12 items questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12 for grading of neuropathy at baseline and by the end of every two VRd cycles.
- The assessment of biological markers:
Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL). through comparing two groups: Group one: (Control group; n=22): which will receive 6 cycles of VRd regimen (each cycle will be given every 28 days).
Group two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.
Detailed description
Multiple myeloma is considered an incurable disease so several regimens are available for the management of multiple myeloma.
Among these regimens there is the bortezomib, lenalidomide and dexamethasone (RVd or VRd) regimen which is the preferred induction regimen for most patients with newly diagnosed multiple myeloma (NDMM).
Bortezomib has hematologic and non-hematologic adverse reactions. From the non-hematologic adverse reactions there is the bortezomib-induced peripheral neuropathy (BIPN) that remains the most intractable common adverse reactions that occur during bortezomib treatment with no recommended therapies available for preventing or treating existing BIPN.
Fenofibrate a peroxisome proliferator-activated receptor-alpha (PPARα) agonist that is widely used in the management of hypercholesterolemia and hypertriglyceridemia has been proposed as a key lipid metabolism modulator and regulator of inflammation.
Preclinical studies showed that treatment with fenofibrate partially reversed and prevented the development of mechanical and cold hypersensitivity induced by paclitaxel through the regulation of peroxisome proliferator-activated receptor-alpha (PPAR-α) expression and decrease neuroinflammation in the dorsal root ganglia (DRG) without decreasing the antitumoral effect of paclitaxel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- At admission, patients will be randomized through sealed envelopes method into two groups to receive either the VRd regimen or the VRd regimen plus fenofibrate 160 mg: Group one: (Control group; n=22): which will receive 6 cycles of VRd regimen (each cycle will be given every 28 days). Group two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate group | Active comparator | Drug: Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet22 participants will receive 6 cycles of (VRd) regimen plus Fenofibrate 160 mg tablet once daily during the period of the 6 cycles. |
| Control group | Other | Drug: Bortezomib + Lenalidomide + Dexamethasone22 participants will receive 6 cycles of VRd regimen (each cycle will be given for 28 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old.
- Newly diagnosed MM patients according to the revised International Myeloma Working Group Diagnostic Criteria for the diagnosis of Multiple Myeloma (IMWG).
- Patients being treated by bortezomib-based VRd chemotherapy regimen.
- Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.
- Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
Key exclusion criteria (13 listed)
- Patients with prior exposure to neurotoxic agents (Cis-platin, vincristine, taxanes, foscarnet, INH, etc..) in the last 6 months.
- Concomitant use of antioxidant vitamins (vitamin A, C, E), anticonvulsants, tricyclic antidepressants, other medications used for neuropathic pain (gabapentin, lamotrigine, carbamazepine).
- Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.
- Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).
- Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tabletBortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22. Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22. Fenofibrate 160 mg tablets orally once daily during the period of the 6 cycles of the(VRd) regimen. | Drug | Fenofibrate group |
| Bortezomib + Lenalidomide + DexamethasoneBortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22. Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22. | Drug | Control group |
Primary outcome
The change in percentage of patients with peripheral neuropathy grade ≥ 2 with the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and NCI-CTCAE, v5.
Time frame: The use of NCI-CTCAE, Version 5, 2017 and "FACT/GOG-Ntx-12" for the grading of peripheral neuropathy will be done at the baseline and by the end of every two VRd cycles ( the duration of each cycle is 28 days) during the 6 VRd cycles duration.
The change in percentage of patients with peripheral neuropathy grade ≥ 2 using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI-CTCAE, v5) ( where the higher the score the more severity of the peripheral neuropathy) and the use of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version (FACT/GOG-NTX-12) to assess (where the higher the score, the better the Quality of life).
1 secondary outcome
The change in serum levels of the measured biological markers Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL).
Time frame: The assessment of serum level of the biological markers Brain -derived neurotrophic factor (ng/ml) and Neuro-filament light chain (pg/ml) will be done at the baseline and within 1 week after the 6th VRd cycle ( the duration of each cycle is 28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Background: PubMed 36724021Jin L, Hua H, Ji Y, Jia Z, Peng M, Huang S. Anti-inflammatory role of fenofibrate in treating diseases. Biomol Biomed. 2023 May 1;23(3):376-391. doi: 10.17305/bb.2022.8534.
- Background: PubMed 24164472Azoulay D, Lavie D, Horowitz N, Suriu C, Gatt ME, Akria L, Perlman R, Braester A, Ben-Yehuda D. Bortezomib-induced peripheral neuropathy is related to altered levels of brain-derived neurotrophic factor in the peripheral blood of patients with multiple myeloma. Br J Haematol. 2014 Feb;164(3):454-6. doi: 10.1111/bjh.12624. Epub 2013 Oct 25. No abstract available.
- Background: PubMed 36802032Cebulla N, Schirmer D, Runau E, Flamm L, Gommersbach S, Stengel H, Zhou X, Einsele H, Reinhold AK, Rogalla von Bieberstein B, Zeller D, Rittner H, Kortum KM, Sommer C. Neurofilament light chain levels indicate acute axonal damage under bortezomib treatment. J Neurol. 2023 Jun;270(6):2997-3007. doi: 10.1007/s00415-023-11624-2. Epub 2023 Feb 18.
- Background: PubMed 33434562Caillaud M, Patel NH, White A, Wood M, Contreras KM, Toma W, Alkhlaif Y, Roberts JL, Tran TH, Jackson AB, Poklis J, Gewirtz DA, Damaj MI. Targeting Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha) to reduce paclitaxel-induced peripheral neuropathy. Brain Behav Immun. 2021 Mar;93:172-185. doi: 10.1016/j.bbi.2021.01.004. Epub 2021 Jan 9.
- Background: PubMed 26604138Esmaeili MA, Yadav S, Gupta RK, Waggoner GR, Deloach A, Calingasan NY, Beal MF, Kiaei M. Preferential PPAR-alpha activation reduces neuroinflammation, and blocks neurodegeneration in vivo. Hum Mol Genet. 2016 Jan 15;25(2):317-27. doi: 10.1093/hmg/ddv477. Epub 2015 Nov 24.
- Background: PubMed 33477371Yamamoto S, Egashira N. Pathological Mechanisms of Bortezomib-Induced Peripheral Neuropathy. Int J Mol Sci. 2021 Jan 17;22(2):888. doi: 10.3390/ijms22020888.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahar M El-Haggar, Professor of Clinical Pharmacy contact
Ashraf M Alaa, BSc of clinical pharmacy principal investigator
clinical pharmacy departement - Faculty of Pharmacy - Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet and Bortezomib + Lenalidomide + Dexamethasone in people with Peripheral Neuropathy and Multiple Myeloma, Neoplasms, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashraf M Alaa, BSc of clinical pharmacy (+201011301390, ashraf.alaa@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in percentage of patients with peripheral neuropathy grade ≥ 2 with the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and NCI-CTCAE, v5. (time frame: The use of NCI-CTCAE, Version 5, 2017 and "FACT/GOG-Ntx-12" for the grading of peripheral neuropathy will be done at the baseline and by the end of every two VRd cycles ( the duration of each cycle is 28 days) during the 6 VRd cycles duration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025005, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.