QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression (QUIREDEX)

July 30, 2013 updated by: PETHEMA Foundation

QUIREDEX: A National, Open-Label, Multicenter, Randomized, Phase III Study of Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety and tolerability of the treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of progression to symptomatic MM will be included.

Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression (Group B).

The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.

The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be stratified and randomized (1:1) to Group A or Group B.

During Treatment Period patients will be evaluated once a month. Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A. During this period we will evaluate response, progression-free survival and global survival every two months.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clínic i Provincial de Barcelona
      • Jerez de la Frontera, Spain
        • Hospital Del Sas de Jerez de La Frontera
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital de la Princesa
      • Madrid, Spain
        • Hospital Dode de Octubre
      • Murcia, Spain
        • Hospital General Univeristario Morales Messeguer
      • Salamanca, Spain
        • Hospital Clínico de Salamanca
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Hospital Clínico de Valencia
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to comply with the protocol requirements
  • Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care
  • Age ≥ 18 years

  • Patient recently diagnosed with smoldering Multiple Myeloma with high risk of progression to symptomatic Multiple Myeloma defined as follows:

    • Bone Marrow infiltration ≥ 10% CPs and M component Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein > 1 g/dl and absence of: hollowed out areas of bone, Hypercalcemia (Calcium-serum < 11.5 mg/dl), Renal Failure (creatinine < 2 mg/dl) and anaemia (Hb > 10 g/dl or at least 2g/dl under normal value.

    • Alternatively, patients with Bone Marrow infiltration with CPs ≥ 10 %, or Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein > 1 g/24h (but not the two of them together) and always without: lytic lesions, Hypercalcaemia, Renal Failure and Anaemia could be admitted with the following additional criteria:

      • % CPs abnormal (CPa/CpcMO) ≥ 95 % with immunodeficiency, defined as diminution of levels of one or two Immunoglobulins of more than 25% respect normal values.
  • ECOG >= 2.
  • The patient has to be able to complain with the protocol visits.
  • Women of childbearing age must have a negative pregnancy test during the 14 days before first dose. And they must accept to use anticonceptive methods beginning during all the study until 4 weeks after the last one.

Exclusion Criteria:

  • Any other organic or mental illness that could make impossible to sign the Inform consent.
  • Patients previously received treatment to smoldering Multiple Myeloma.
  • Pregnancy or breast-feed women
  • Hollowed out areas of bone, anaemia, renal failure and Hypercalcemia

  • The following laboratory data:

    • Absolute neutrophil count ≥ 1000/mm3
    • Platelet count ≥ 75000/mm3
    • Aspartate transaminase (AST) or Alanine transaminase (ALT ) ≤ 3 x the upper limit of normal.
    • Total bilirubin: ≤ 2 x the upper limit of normal.
  • Patients with >= Grade 2 peripheral neuropathy within 14 days before enrolment.
  • Patient with a previous clinical history of another malignant illness except for squamous cell carcinoma or skin cancer or cervical cancer except the patient could be free of symptoms during ≥ 5 years.
  • Patient has hypersensitivity or adverse events previous to lenalidomide or Dexamethasone.
  • Patient who has major surgery during the 4th weeks previous inclusion.
  • Patient has received other investigational drugs within 30 days before enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lenalidomide + Dexamethasone for 9 cycles and maintenance
Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
No Intervention: 2
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the efficacy of the treatment in response rate terms
Time Frame: one year
one year
Evaluate the safety and tolerability of the treatment
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Mª Victoria Mateos, Dr, Hospital Clinico Universitario de Salamanca
  • Principal Investigator: Jesús San Miguel, Dr, Hospital Clinico Universitario de Salamanca
  • Principal Investigator: Joan Bladé, Dr, Hospital Clinic of Barcelona
  • Principal Investigator: Juan José Lahuerta, Dr, Hospital Doce de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 28, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-000649-36
  • QUIREDEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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