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

Multiple Myeloma Clinical Trial

— QUIREDEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480363
• Other study ID #: 2007-000649-36
• Secondary ID: QUIREDEX
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2007
• Last updated: July 30, 2013
• Start date: May 2007
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Maintenance with lower doses of lenalidomide and dexamethasone
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance

Locations

Country	Name	City	State
Spain	Hospital germans Trias i Pujol	Badalona
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del SAS de Jerez de la Frontera	Jerez de la Frontera
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Dode de Octubre	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital General Univeristario Morales Messeguer	Murcia
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Universitario la Fe	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
PETHEMA Foundation	Celgene Corporation

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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Richardson PG, Blood E, Mitsiades CS, Jagannath S, Zeldenrust SR, Alsina M, Schlossman RL, Rajkumar SV, Desikan KR, Hideshima T, Munshi NC, Kelly-Colson K, Doss D, McKenney ML, Gorelik S, Warren D, Freeman A, Rich R, Wu A, Olesnyckyj M, Wride K, Dalton WS, Zeldis J, Knight R, Weller E, Anderson KC. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006 Nov 15;108(10):3458-64. Epub 2006 Jul 13. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM		one year	No
Secondary	Evaluate the efficacy of the treatment in response rate terms		one year	No
Secondary	Evaluate the safety and tolerability of the treatment		one year	Yes

External Links

•   Pethema Foundation web
•   Spanish association of Haematology