Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

— PrObe-L  

Official title:

Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692339
• Other study ID #: CC-5013-MM-028
• Status: Completed
• Start date: February 25, 2016
• Est. completion date: December 12, 2018

Study information

• Verified date: June 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).

Description:

This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by evaluation of adverse events of special interest (infections, gastrointestinal events, thrombocytopenia, neutropenia, febrile neutropenia, and thromboembolism). In addition, due to the scarce information regarding the impact of frailty in Len/Dex treatment in rrMM, this study will prospectively assess Len/Dex safety and effectiveness by patient frailty groups. The following study assessments will be performed: - Recruitment: patients will be recruited within 15 days after the start of Len/Dex (from day 1 to day 15). In case patients are not recruited at the day of Len/Dex start (day 1), baseline information respective to this day will be collected retrospectively. - Treatment period: during this period, the following assessments will be carried out: - Every 30 days (± 5 days) for adverse events, changes in concomitant medication and change in Len/Dex dose. - Every 90 days (± 15 days) for the remaining information to be collected in the treatment period - Assessment at the end of Len/Dex treatment (until 5 days after end of treatment). Follow-up assessment 90 days (± 15 days) after the end of Len/Dex treatment. No visits were predefined for this study. Study data is planned to be collected when the patient goes to the study site for a clinical routine visit. No assessments will be imposed for the purposes of this study. If the patient goes to the clinical routine visit at a date out of the time intervals predicted above, no information will be collected. Information will be collected in the context of routine clinical practice. The patient will be followed until the end of Len/Dex treatment, death or discontinuation for any reason for a maximum period of 36 months, Patients within treatment after this maximum period will stop being followed in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 18 years or higher.

2. Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study

3. Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) -

Exclusion Criteria:

1. Pregnant or lactating patients

2. Female patients of childbearing potential unable or unwilling to use effective

contraceptive methods, as stated in the summary of product characteristics:

• Implant.
• Levonorgestrel-releasing intrauterine system.
• Medroxyprogesterone acetate depot.
• Tubal sterilisation.
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses. Ovulation inhibitory progesterone-only pills (i.e. desogestrel).
• Male patients unable to follow or comply with the required contraceptive measures stated in the SmPC (use of condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception [even if the man has had a vasectomy], during treatment and for 1 week after dose interruptions and/or cessation of treatment)

3. Hypersensitivity to the active substance or any of the excipients

4. Patients participating in a clinical trial -

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide
Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
• Dexamethasone
Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle

Locations

Country	Name	City	State
Portugal	Hospital Garcia Orta, E.P.E.	Almada
Portugal	Hospital Professor Doutor Fernando Fonseca, E.P.E.	Amadora
Portugal	Hospital Central de Faro	Faro
Portugal	Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos	Lisboa
Portugal	Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria	Lisboa
Portugal	Fundação Champalimaud	Lisboa
Portugal	Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE	Lisboa
Portugal	Centro Hospitalar de São João, EPE - Hospital de São João	Porto
Portugal	Centro Hospitalar do Porto - Hospital de Santo António	Porto
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Portugal	Hospital de São Teotónio, E.P.E.	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse events of special interest during Len/Dex therapy	Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE	Up to approximately 72 months
Secondary	Incidence (number) of thromboembolism	Identification of the incidence of deep venous thrombosis and pulmonary embolism) during Lenalidomide and Dexamethasone study drug treatment.	Up to approximately 72 months
Secondary	Duration of Len/Dex treatment over the course of the study	Defined as the time between the start of Len/Dex treatment until discontinuation or death (whichever occurs first)	Up to approximately 72 months
Secondary	Number of patients with good and poor compliance to lenalidomide and dexamethasone	Compliance will be measured by the capsule/tablet count, after the end of study treatment	Up to approximately 72 months
Secondary	Type and frequency of prophylaxis treatment for prevention of thromboembolism	Type and frequency of prophylaxis treatment for prevention of thromboembolism during Lenalidomide/Dexamethasone study treatment.	Up to 36 months