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 (DELICATESSE)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloma Multiple
• Intervention / Treatment: Other: dermo-cosmetic product

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cyrille Touzeau; Phone Number: 02 53 48 24 05; Email: cyrille.touzeau@chu-nantes.fr
• Study Contact Backup: Name: Nicoletta Libera LILLI; Phone Number: 02 76 64 37 83; Email: nicolettalibera.lilli@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group preventive	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.
Other: group curative	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total DLQI score after 1 month and 6 months (or earlier if progression) post use of support products.		1 month/6 month
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: RC23_0530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No