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

• Status: Recruiting
• Trial end date: 2023-09-29
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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 -