NCT06418750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 24, 2024

Last Update Submit

April 15, 2026

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

Study Arms (2)

group preventive

OTHER
Other: dermo-cosmetic product

group curative

OTHER
Other: dermo-cosmetic product

Interventions

dermo-cosmetic productOTHER

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.

group curativegroup preventive

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touzeau Cyrille

Nantes, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups studied: preventive and curative.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 17, 2024

Study Start

July 4, 2024

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)