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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-25

Study Completion Date

2018-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

NCT00420849

Multiple Myeloma

COMPLETED PHASE3

Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

NCT01019174

Multiple Myeloma

COMPLETED PHASE1/PHASE2

Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone

NCT03809780

Multiple Myeloma

ACTIVE_NOT_RECRUITING PHASE2

Study of Lenalidomide and Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma

NCT01593410

Multiple Myeloma

COMPLETED PHASE2

Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide

NCT01794039

Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lenalidomide/Dexamethasone

Standard of Care doses for relapsed/refractory multiple myeloma

Lenalidomide

Intervention Type DRUG

Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle

Dexamethasone

Intervention Type DRUG

Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lenalidomide

Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle

Intervention Type DRUG

Dexamethasone

Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Revlimid Decadron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No