Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma (FIRST-NIS)

A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma

The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma

Detailed Description

The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients.

After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44787
    • Hämatologisch-Onkologische Schwerpunktpraxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
• Indication for treatment as assessed by the treating physician
• Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
• No previous systemic therapy for multiple myeloma
• Ineligibility for transplantation
• Aged 18 years or older
• Written informed consent signed
• The conditions of the risk management plan/pregnancy prevention program (refer to the SmPC Revlimid®) must be followed by female and male patients
• Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician

Exclusion Criteria:

• Pregnant or breast-feeding women
• Any objections or contraindications according to the SmPC

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) rate at 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess Median Overall Survival (OS)		84 month
To assess safety and tolerability via AE and SAE reporting	AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.	24 months
To assess Quality of Life (EORTC QLQ-C30 and MY20	QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months	24 months
To assess duration of hospitalisation periods	To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period.	24 months
Overall Response Rate		24 months
Median Progression-free survival (PFS)		84 months
Median Time to Progression (TTP)		84 months
Median Time to Response (TTR)		24 months
Duration of Response		84 months
Reason for treatment discontinuation		84 months

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Investigators: Principal Investigator: Holger Nückel, Professor, Hämatologisch-Onkologische Schwerpunktpraxis

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2015
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimated): September 2, 2015

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: IOM-12315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO