Observational Study of Home Administration of Carfilzomib

NCT04621955 | Withdrawn

• 1 other identifier: 20167745
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.

Conditions

Multiple Myeloma; Hematologic Diseases

Keywords

Home administration of chemotherapy; Relapsed and/or refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Description of feasibility of home administration

  Percentage of patients still in the home administration program 4 cycles mixed home/hospital and who did not discontinue due to AE (adverse event) or PD (progressive disease)

  through study completion

Secondary Outcomes (13)

• Description of quality of life/satisfaction of the program

  through study completion

• Description of patients acceptability

  At screening

• Description of patient characteristics: performance status

  through study completion

• Description of patient characteristics: professionally active at diagnosis

  At screening

• Description of patient characteristics: professionally active at study entry

  At screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple myeloma patients on KRd treatment

You may qualify if:

• Age ≥ 18 years
• Ability to understand the informed consent and willingness to provide an informed consent signature
• Signed and dated written informed consent available (for participation in the home administration program or for agreement on data-collection in case of refusal to participate (reasons for refusal))
• Diagnosis of a relapsed and/or refractory multiple myeloma (refractory meaning nonresponsive (stable or progressive disease) during treatment or disease progression within 60 days of treatment discontinuation)
• Patient on KRd treatment (according to reimbursement criteria) having already received a minimum of 2 and a maximum of 6 full cycles of KRd in the hospital
• Patient with good tolerance of KRd and expected to receive ≥ 6 cycles based on clinical assessment of the treating physician
• Patient willing to receive at home intravenous administration of carfilzomib (only for patients who accepted the home administration program of the study)

You may not qualify if:

• Lactating or pregnant females
• Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Program of lenalidomide are met and unless use effective contraception measures during and for one month following treatment. Male patients should use contraception and refrain form sperm donation for at least 90 days after the last dose of carfilzomib.
• Patients who already received carfilzomib home administration
• Any contra-indication for continuation of treatment with carfilzomib

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (5)

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Clinique Saint-Pierre Ottignies

Ottignies, 1340, Belgium

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michel Delforge

  UZ Leuven Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: November 9, 2020
• Study Start: June 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

BE (5)