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

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ClinicalTrials.gov Identifier: NCT00480363

Recruitment Status : Completed

First Posted : May 30, 2007

Last Update Posted : July 31, 2013

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Celgene Corporation

Information provided by:

PETHEMA Foundation

Tracking Information

First Submitted Date ^ICMJE

May 28, 2007

First Posted Date ^ICMJE

May 30, 2007

Last Update Posted Date

July 31, 2013

Study Start Date ^ICMJE

May 2007

Actual Primary Completion Date

December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Procedure: Maintenance with lower doses of lenalidomide and dexamethasone

After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance

Study Arms ^ICMJE

Experimental: 1
Lenalidomide + Dexamethasone for 9 cycles and maintenance

Intervention: Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
No Intervention: 2
Observation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

July 2013

Actual Primary Completion Date

December 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00480363

Other Study ID Numbers ^ICMJE

2007-000649-36
QUIREDEX

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Pethema

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

PETHEMA Foundation

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Celgene Corporation

Investigators ^ICMJE

Principal Investigator:	Mª Victoria Mateos, Dr	Hospital Clinico Universitario de Salamanca
Principal Investigator:	Jesús San Miguel, Dr	Hospital Clínico Universitario de Salamanca
Principal Investigator:	Joan Bladé, Dr	Hospital Clinic of Barcelona
Principal Investigator:	Juan José Lahuerta, Dr	HOSPITAL DOCE DE OCTUBRE

PRS Account

PETHEMA Foundation

Verification Date

July 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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