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

Sponsor
iOMEDICO AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02537808
Collaborator
(none)
172
Enrollment
1
Location
98.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    172 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
    Actual Study Start Date :
    Jun 23, 2015
    Actual Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) rate at 24 months [24 months]

    Secondary Outcome Measures

    1. To assess Median Overall Survival (OS) [84 month]

    2. To assess safety and tolerability via AE and SAE reporting [24 months]

      AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.

    3. To assess Quality of Life (EORTC QLQ-C30 and MY20 [24 months]

      QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months

    4. To assess duration of hospitalisation periods [24 months]

      To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period.

    5. Overall Response Rate [24 months]

    6. Median Progression-free survival (PFS) [84 months]

    7. Median Time to Progression (TTP) [84 months]

    8. Median Time to Response (TTR) [24 months]

    9. Duration of Response [84 months]

    10. Reason for treatment discontinuation [84 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hämatologisch-Onkologische Schwerpunktpraxis Bochum Germany 44787

    Sponsors and Collaborators

    • iOMEDICO AG

    Investigators

    • Principal Investigator: Holger Nückel, Professor, Hämatologisch-Onkologische Schwerpunktpraxis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    iOMEDICO AG
    ClinicalTrials.gov Identifier:
    NCT02537808
    Other Study ID Numbers:
    • IOM-12315
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Feb 2, 2022