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
- Conditions
- Myeloma Multiple
- Interventions
- Other: dermo-cosmetic product
- Registration Number
- NCT06418750
- Lead Sponsor
- Nantes University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- MM patient.
- 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.
- Patient with written consent.
- 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.
- Patients with atomic dermatitis (eczema)
- Patients allergic to one or more components of the products tested.
- Pregnant or breast-feeding women.
- Patients who are minors or under legal protection (guardianship or safeguard of justice).
- Patient not affiliated to a social security scheme.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group preventive dermo-cosmetic product - group curative dermo-cosmetic product -
- Primary Outcome Measures
Name Time Method Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) within one month of starting to use support products. 1 month To evaluate the efficacy of a range of dermo-cosmetic products in preventing/limiting cutaneous and nail toxicity induced by anti-GPRC5D bispecific Ac in MM patients according to the NCI-CTCAE V5.0 scale.
- Secondary Outcome Measures
Name Time Method Total DLQI score after 1 month and 6 months (or earlier if progression) post use of support products. 1 month/6 month Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) occurring after 6 months (or earlier if progression) of use of support products. 6 month To evaluate the efficacy of a range of dermo-cosmetic products in preventing/limiting cutaneous and nail toxicity induced by anti-GPRC5D bispecific Ac in MM patients according to the NCI-CTCAE V5.0 scale.
Pain score after 1 month and 6 months (or earlier if progression) post use of support products. 1 month/6 month Satisfaction at 6 months (or earlier if progression) assessed on a Likert scale by the doctor and patient, for each product in the range tested. 6 month