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

Sponsor

Celgene (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03001804

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice

Actual Study Start Date :

Jun 30, 2017

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cohort A 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 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

Arm

Intervention/Treatment

Cohort A

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

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

Outcome Measures

Primary Outcome Measures

Number of patients receiving dexamethasone after 6 months of treatment [up to 2 years]
Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment

Secondary Outcome Measures

Number of patients with Deep Venous Thrombosis (VTE) prophylaxis [up to 2 years]
Number of patients that receive VTE prophylaxis
Over all response rate (ORR) [up to 2 years]
Number of patients that achieve a response
Adverse Events (AEs) [up to 2 years]
Number of patients with an adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Landeskrankenhaus Kirchdorf	Kirchdorf	Austria	4560
2	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Austria	9020
3	Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie	Linz	Austria	4020
4	Ordensklinikum Linz GmbH Elisabethinen	Linz	Austria	4020
5	Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1	Ried	Austria	4910
6	Landeskrankenhaus Steyr - Innere Medizin	Steyr	Austria	4400
7	Klinische Abteilung für Hämatologie und Hämostaseologie	Vienna	Austria	1090
8	St. Josef Krankenhaus	Vienna	Austria	1130
9	Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie	Vienna	Austria	1160
10	Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin	Vöcklabruck	Austria	4840
11	AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie	Wien	Austria	1090
12	LKH Wiener Neustadt, Innere Medizin	Wr. Neustadt	Austria	2700