NCT03001804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

5.5 years

First QC Date

December 19, 2016

Last Update Submit

June 8, 2023

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaRevlimidLenalidomideNon-transplantable

Outcome Measures

Primary Outcomes (1)

  • Number of patients receiving dexamethasone after 6 months of treatment

    Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment

    up to 2 years

Secondary Outcomes (3)

  • Number of patients with Deep Venous Thrombosis (VTE) prophylaxis

    up to 2 years

  • Over all response rate (ORR)

    up to 2 years

  • Adverse Events (AEs)

    up to 2 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for therapy of untreated multiple myeloma, where stem cell transplantation cannot be performed

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant and lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Landeskrankenhaus Kirchdorf

Kirchdorf, 4560, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie

Linz, 4020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020, Austria

Location

Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1

Ried, 4910, Austria

Location

Landeskrankenhaus Steyr - Innere Medizin

Steyr, 4400, Austria

Location

AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie

Vienna, 1090, Austria

Location

Klinische Abteilung für Hämatologie und Hämostaseologie

Vienna, 1090, Austria

Location

St. Josef Krankenhaus

Vienna, 1130, Austria

Location

Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie

Vienna, 1160, Austria

Location

Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin

Vöcklabruck, 4840, Austria

Location

LKH Wiener Neustadt, Innere Medizin

Wiener Neustadt, 2700, Austria

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 23, 2016

Study Start

June 30, 2017

Primary Completion

December 16, 2022

Study Completion

December 16, 2022

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

AU(12)