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Trial Title:
Evaluation of a Range of Dermo-cosmetic Products to Treat Skin and Nail Toxicity Linked to Bispecific Anti-GPRC5D Bispecific Antibodies in Multiple Myeloma Patients". Myeloma". Descriptive Pilot Study
NCT ID:
NCT06418750
Condition:
Myeloma Multiple
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Two groups studied: preventive and curative.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
dermo-cosmetic product
Description:
For patients in the preventive group, treatment with hand serum, gloves/slippers and
fortifying solution/dissolving oil will be started on the day of the first administration
of Ac bispecific. In the curative group, treatment will begin on inclusion in the study
and will be adapted to the lesions present on D0. Treatment will be readjusted on a
weekly basis according to the lesions present at the time of the follow-up visit.
Arm group label:
group curative
Arm group label:
group preventive
Summary:
The aim of this study is to assess the efficacy of range of dermo-cosmetic products
(hand/feet serum, nail strengthening solution nail strengthening solution, dissolving oil
and gloves/slippers) based on natural products and designed for cancer patients)on
bispecific Ac-induced skin and nail toxicity in MM patients treated with anti-CD3xGPRC5D
bispecific antibodies.
The effects of supportive care products will be studied as a preventive measure in
patients starting treatment with bispecific Ac and as a curative measure in patients
undergoing treatment.
Patients will be able to apply the products directly at home according to the study
schedule, and a skin and nail toxicity skin and nail toxicity will be performed each time
the patient comes for administration of bispecific Ac. Follow-up will be for a total of 6
months (or less if progression occurs earlier), and patients will be asked to complete a
quality-of-life questionnaire at protocol inclusion and after 1 month and 6 months of
supportive care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. MM patient.
2. Patient starting anti-GPRC5D bispecific Ac therapy OR patient undergoing anti-GPRC5D
bispecific Ac therapy with NCI-NCTCAE V5.0 grade ≥2 skin and nail toxicity.
3. Patient with written consent.
Exclusion Criteria:
1. Patients treated or considering treatment with dermatological drugs
(dermocorticoids) normally used for hand-foot syndrome OR dermo-cosmetic products
(serum or reparative solutions) other than those tested.
2. Patients with atomic dermatitis (eczema)
3. Patients allergic to one or more components of the products tested.
4. Pregnant or breast-feeding women.
5. Patients who are minors or under legal protection (guardianship or safeguard of
justice).
6. Patient not affiliated to a social security scheme.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
July 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418750
