Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients

Celgene

Status: Completed

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT03001804

CC-5013-MM-037

Details and patient eligibility

About

The aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered indication under practice conditions.

Full description

Multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015 REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised It is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with Revlimid.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent
• Age ≥ 18 years
• Newly diagnosed Multiple Myeloma
• Not suitable for stem cell transplantation
• Appropriate methods of contraception according to the Risk Minimization Program (RMP)
• Adequate thrombosis prophylaxis

Exclusion criteria

• Pregnant and lactating females
• No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)

Trial design

29 participants in 2 patient groups

Cohort A

Description:

Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr \< 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (\>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity

Cohort B

Description:

Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr \< 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr \< 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (\>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity