## Protocol Section
### Identification Module
**NCT ID:** NCT06418750

**Acronym:** DELICATESSE

**Brief 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

**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.

#### Organization Study ID Info
**ID:** RC23_0530
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Myeloma Multiple

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Two groups studied: preventive and curative.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: dermo-cosmetic product

**Label:** group preventive

**Type:** OTHER

#### Arm Group 2

**Intervention Names:**

- Other: dermo-cosmetic product

**Label:** group curative

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group curative

- group preventive

**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.

**Name:** dermo-cosmetic product

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) within one month of starting to use support products.

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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.

**Time Frame:** 6 month

**Measure:** Total DLQI score after 1 month and 6 months (or earlier if progression) post use of support products.

**Time Frame:** 1 month/6 month

**Measure:** Pain score after 1 month and 6 months (or earlier if progression) post use of support products.

**Time Frame:** 1 month/6 month

**Measure:** 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.

**Time Frame:** 6 month

### Eligibility Module

**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.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cyrille.touzeau@chu-nantes.fr

**Name:** Cyrille Touzeau

**Phone:** 02 53 48 24 05

**Role:** CONTACT

**Contact 2:**

**Email:** nicolettalibera.lilli@chu-nantes.fr

**Name:** Nicoletta Libera LILLI

**Phone:** 02 76 64 37 83

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: HIGH

- As Found: Myeloma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Myeloma

### Condition Browse Module - Meshes

- ID: D000009101

- Term: Multiple Myeloma

- ID: D000054219

- Term: Neoplasms, Plasma Cell

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M20194

- Name: Antibodies, Bispecific

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
