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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00480363
First received: May 28, 2007
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the efficacy of the treatment in response rate terms [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of the treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2007
Study Completion Date: July 2013
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480363

Locations
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 Dode de Octubre
Madrid, Spain
Hospital de la Princesa
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 Universitario la Fe
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Celgene Corporation
Investigators
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
  More Information

Additional Information:
Publications:
20. Zangari M, Tricot G, Zeldis J, et al. Results of phase I study of CC-5013 for the treatment of multiple myeloma patients who relapse after high dose chemotherapy (HDCT). Blood 2001; 98:775a (Abstract 3226)
23. Baz R, Choueiri TK, Jawde RA, et al. Doxil (D), Vincristine (V), Reduced Frequency Dexamethasone (d) and Revlimid(R) (DVd-R) Results in a High Response Rate in Patients with Refractory Multiple Myeloma(RMM).Blood 2005; 106: 2559.
27. Palumbo A, Falco P, Musto P, et al. Oral RevlimidR Plus Melphalan and Prednisone (R-MP) for Newly Diagnosed Multiple Myeloma. Blood 2005; 106: 785.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pethema
ClinicalTrials.gov Identifier: NCT00480363     History of Changes
Other Study ID Numbers: 2007-000649-36, QUIREDEX
Study First Received: May 28, 2007
Last Updated: July 30, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Smoldering Multiple Myeloma
PETHEMA
Smoldering

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 22, 2014