QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression (QUIREDEX)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00480363 |
Recruitment Status :
Completed
First Posted : May 30, 2007
Last Update Posted : July 31, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Procedure: Maintenance with lower doses of lenalidomide and dexamethasone | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | July 2013 |
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
|
- 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 ]
- 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 ]
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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480363
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, Spain |
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pethema |
ClinicalTrials.gov Identifier: | NCT00480363 |
Other Study ID Numbers: |
2007-000649-36 QUIREDEX |
First Posted: | May 30, 2007 Key Record Dates |
Last Update Posted: | July 31, 2013 |
Last Verified: | July 2013 |
Smoldering Multiple Myeloma PETHEMA Smoldering |
Multiple Myeloma Neoplasms, Plasma Cell Smoldering Multiple Myeloma 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 |
Precancerous Conditions Hypergammaglobulinemia Dexamethasone Lenalidomide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |