DARZALEX FASPRO® for Peripheral Neuropathy (Dara-MGUS Trial)
Palo Alto (17 mi)Overseen byKimberley Doucette, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Georgetown University
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing an injectable medication called DARZALEX FASPRO® in patients with MGUS who have nerve damage. The goal is to see if this treatment can improve their nerve-related symptoms. The medication works by helping the immune system target abnormal cells and improving absorption of the drug.
Is the drug Daratumumab a promising treatment for peripheral neuropathy?The provided research articles do not mention Daratumumab or its effectiveness for peripheral neuropathy, so we cannot determine if it is a promising treatment based on this information.2681013
What safety data is available for DARZALEX FASPRO® in treating peripheral neuropathy?The provided research does not contain safety data for DARZALEX FASPRO® (daratumumab) related to peripheral neuropathy. The studies focus on other treatments and conditions, such as lacosamide for diabetic neuropathy, α1 receptor antagonists for paclitaxel-induced neuropathy, and other chemotherapy-induced neuropathies. For specific safety data on DARZALEX FASPRO®, consult clinical trial results or official drug safety information from regulatory agencies.2791112
What data supports the idea that DARZALEX FASPRO® for Peripheral Neuropathy is an effective treatment?The available research does not provide specific data on DARZALEX FASPRO® for treating Peripheral Neuropathy. Instead, it discusses other treatments like rituximab and fludarabine for different types of neuropathy. Without direct evidence or studies on DARZALEX FASPRO® for Peripheral Neuropathy, we cannot conclude its effectiveness for this condition based on the provided information.13456
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications for conditions like diabetes, vitamin deficiency, or chronic alcohol consumption, you may be excluded from the trial. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
Adults with MGUS-related peripheral neuropathy, who have certain levels of nerve damage and disability, can join. They must have good bone marrow and liver function, use effective birth control, and not be pregnant or breastfeeding. People with prior daratumumab exposure, HIV, hepatitis B/C, other cancers like multiple myeloma or serious medical conditions that could risk safety are excluded.Inclusion Criteria
I have chronic demyelinating neuropathy and MGUS with an IgM peak.
I have trouble with coordination or my pain level is above moderate.
I am not able to become pregnant or I have a negative pregnancy test before starting the study.
I have nerve damage related to high anti-MAG levels.
I can take care of myself but may not be able to do heavy physical work.
Exclusion Criteria
My lung function is less than half of what is expected for someone my age and size.
I have a serious heart condition.
I do not have any severe illnesses that could risk my safety in the study.
I have been treated with daratumumab or other anti-CD38 therapies.
I am not pregnant, breastfeeding, imprisoned, or under the legal adult age.
I have been diagnosed with HIV.
I have a diagnosis of a specific blood or bone marrow cancer.
I have had severe or uncontrolled asthma in the last 2 years.
Treatment Details
The trial tests DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for improving nerve damage in MGUS patients. Participants will undergo initial testing to assess their condition before receiving the medication weekly for two months then every other week until month six.
1Treatment groups
Experimental Treatment
Group I: Daratumumab and hyaluronidase-fihjExperimental Treatment1 Intervention
Daratumumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Darzalex for:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
🇺🇸 Approved in United States as Darzalex for:
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a clinic near you
Research locations nearbySelect from list below to view details:
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, NJ
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington, United States
Loading ...
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
Janssen, LPIndustry Sponsor
References
Successful treatment of IgM paraproteinaemic neuropathy with fludarabine. [2023]To evaluate the response of four patients with IgM paraproteinaemic neuropathy to a novel therapy-pulsed intravenous fludarabine.
Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. [2018]This open-label follow-on trial aimed to investigate long-term safety and efficacy of lacosamide in patients with painful diabetic neuropathy.
Placebo-controlled trial of rituximab in IgM anti-myelin-associated glycoprotein antibody demyelinating neuropathy. [2015]Report a double-blind, placebo-controlled study of rituximab in patients with anti-MAG demyelinating polyneuropathy (A-MAG-DP).
Neurophysiological and clinical responses to rituximab in patients with anti-MAG polyneuropathy. [2015]Rituximab treatment has shown clinical improvement in anti-myelin associated glycoprotein (MAG) polyneuropathy. We analyzed scores of clinical scales and the most sensitive electrophysiological parameters before and after immunomodulating treatment with rituximab in a group of patients affected by anti-MAG demyelinating polyneuropathy.
Drugs for the treatment of peripheral neuropathies. [2018]Peripheral neuropathies are frequent in association with systemic diseases as well as isolated disorders. Recent advances in the therapy of specific neuropathies led to the approval of new drugs/treatments. This review selected those peripheral neuropathies where the most recent approvals were provided and revised the potential future developments in diabetic and toxic-induced neuropathies, although they do not have a currently available causal therapy in view of their epidemiological and social relevance. Data have been extracted from the most important published trials and from clinical experience. In addition, data from the Food and Drug Administration and European Medicine Agency indications on the treatment of the selected peripheral neuropathies and from recently updated international guidelines have also been included. The website of the U.S. National Institutes of Health www.clinicaltrials.gov registry has been used as the reference database for phase III clinical trials not yet published or ongoing. This review gives a general overview of the most recent advances in the treatment of amyloid, inflammatory, and paraproteinemic peripheral neuropathies. Moreover, it briefly describes the unmet medical need in disabling and frequent conditions, such as diabetic and chemotherapy-induced neuropathy, highlighting the most promising therapeutic approaches to their treatment.
Pharmacotherapy for diabetic peripheral neuropathy pain and quality of life: A systematic review. [2022]To systematically assess the effect of pharmacologic treatments of diabetic peripheral neuropathy (DPN) on pain and quality of life.
Aldose reductase inhibitor ranirestat significantly improves nerve conduction velocity in diabetic polyneuropathy: A randomized double-blind placebo-controlled study in Japan. [2023]Diabetic polyneuropathy is one of the most frequent diabetic complications, and impairs patients' quality of life. We evaluated the efficacy and safety of ranirestat (40 mg/day) in patients with diabetic polyneuropathy.
Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain. [2022]Label="AIMS/INTRODUCTION" NlmCategory="OBJECTIVE">Diabetic peripheral neuropathic pain (DPNP) affects the functionality, mood and sleep patterns of patients with diabetes. Mirogabalin, an α2 δ ligand with a slower dissociation for α2 δ-1 versus α2 δ-2 subunits, showed efficacy and safety in a randomized, double-blind, placebo-controlled, 14-week study in Asian patients with DPNP. This open-label extension study evaluated the long-term safety and efficacy of mirogabalin in Asian patients with DPNP.
A Fenofibrate Diet Prevents Paclitaxel-Induced Peripheral Neuropathy in Mice. [2021]Paclitaxel-induced peripheral neuropathy (PIPN) is a major adverse effect of this chemotherapeutic agent that is used in the treatment of a number of solid malignancies. PIPN leads notably to burning pain, cold and mechanical allodynia. PIPN is thought to be a consequence of alterations of mitochondrial function, hyperexcitability of neurons, nerve fiber loss, oxidative stress and neuroinflammation in dorsal root ganglia (DRG) and spinal cord (SC). Therefore, reducing neuroinflammation could potentially attenuate neuropathy symptoms. Peroxisome proliferator-activated receptor-α (PPAR-α) nuclear receptors that modulate inflammatory responses can be targeted by non-selective agonists, such as fenofibrate, which is used in the treatment of dyslipidemia.
Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. [2021]Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin's safety and efficacy.
Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database. [2022]Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse event associated with several antineoplastic drugs; however, the precise risks and time course of reactions of particular drugs are not clearly understood. The aim of this study was to evaluate the relationship between anticancer agents and CIPN development using data from the Japanese Adverse Drug Event Report (JADER) database and to characterize the time-to-onset and outcomes of CIPN. Chemotherapy-induced peripheral neuropathy was defined using the Medical Dictionary for Regulatory Activities preferred terms. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence interval for signal detection. Data of nine Anatomical Therapeutic Chemical (ATC) drug categories correlated with CIPN development, in addition to the data of the time-to-onset and outcomes. Among 622,289 reports in the JADER database from April 2004 to March 2020, there were 1883 reports of adverse events corresponding to peripheral neuropathy. The ROR (95% confidence interval) for vinblastine, sorbent-based paclitaxel (sb-PTX), oxaliplatin, and bortezomib was 20.4 (12.5-33.4), 13.6 (11.9-15.7), 26.2 (23.6-29.1), and 30.8 (26.6-35.8), respectively. The median duration (interquartile range) to CIPN development after the administration of vinca alkaloids and analogues, taxanes, platinum compounds, and monoclonal antibodies was 11.0 (5.0-46.5), 22.5 (6.0-82.5), 22.0 (6.0-68.5), and 32.5 (11.3-73.8) days, respectively. The median duration (interquartile range) of sb-PTX and nanoparticle albumin-bound (nab)-PTX was 35.0 (7.0-94.0) and 5.5 (3.0-29.3) days, respectively. Our analysis of records in the JADER database revealed several drugs associated with a high risk for CIPN development. In particular, the development of CIPN after vinca alkaloid administration should be closely monitored for 2 weeks after administration. CIPN caused by nab-PTX showed significantly faster onset than that by sb-PTX. Patients who receive taxanes or monoclonal antibodies often do not show an improvement; accordingly, early treatment is required.
Inhibitory Effect of α1 Receptor Antagonists on Paclitaxel-Induced Peripheral Neuropathy in a Rodent Model and Clinical Database. [2023]The anticancer drug, paclitaxel, is widely used for ovarian, breast, non-small cell lung, and gastric cancers; however, it induces peripheral neuropathy as a side effect. There is insufficient evidence-based prophylaxis, and new prophylaxis and treatment methods are required. We examined the effect of α1-receptor antagonists on paclitaxel-induced peripheral neuropathy using Sprague-Dawley rats and a large adverse event database. The repeated administration of doxazosin or tamsulosin significantly reduced the response threshold to paclitaxel administration in animal models. In the sciatic nerve tissue, axonal degeneration and myelopathy were significantly suppressed. Furthermore, an analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database suggested that the group using α1 inhibitors showed a lower reporting rate for paclitaxel-related peripheral neuropathy than the group that did not use these inhibitors (odds ratio (95% confidence interval): tamsulosin 0.21 (0.08−0.56), p
Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice. [2023]Painful diabetic peripheral neuropathy (PDPN) is common and difficult to treat with limited treatment options. We assessed the efficacy of frequency rhythmic electromagnetic neural stimulation (FREMS) in patients with PDPN.