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

Myeloma Multiple Clinical Trial

— DELICATESSE  

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418750
• Other study ID #: RC23_0530
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Cyrille Touzeau
• Phone: 02 53 48 24 05
• Email: cyrille.touzeau[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

Other:
• dermo-cosmetic product
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) within one month of starting to use support products.	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.	1 month
Secondary	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.	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.	6 month
Secondary	Total DLQI score after 1 month and 6 months (or earlier if progression) post use of support products.		1 month/6 month
Secondary	Pain score after 1 month and 6 months (or earlier if progression) post use of support products.		1 month/6 month
Secondary	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