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Sponsors and Collaborators: |
PETHEMA Foundation Celgene Corporation |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00480363 |
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 Procedure: Observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 120 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lenalidomide + Dexamethasone for 9 cycles and maintenance
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Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
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2: No Intervention
Lenalidomide + Dexamethasone for 9 cycles and observation (no maintenance)
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Procedure: Observation
After 9 cycles of lenalidomide and dexamethasone, it follows with observation
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient recently diagnosed with smoldering Multiple Myeloma with high risk of progression to symptomatic Multiple Myeloma defined as follows:
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:
Exclusion Criteria:
The following laboratory data:
Contact: Mateos Mª Victoria, Dr | 34 923 291 100 | mvmateos@usal.es |
Spain | |
Hospital Clínico de Salamanca | Recruiting |
Salamanca, Spain | |
Contact: Jesús San Miguel, Dr | |
Hospital Clínic i Provincial de Barcelona | Recruiting |
Barcelona, Spain | |
Contact: Joan Blade, Dr | |
Hospital Dode de Octubre | Recruiting |
Madrid, Spain | |
Contact: JUan José Lahuerta, Dr | |
Hospital Universitario la Fe | Recruiting |
Valencia, Spain | |
Contact: javier de la Rubia, Dr | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain | |
Contact: Anna Sureda, Dr | |
Hospital germans Trias i Pujol | Recruiting |
Badalona, Spain | |
Contact: Albert Oriol, Dr | |
Hospital del SAS de Jerez de la Frontera | Recruiting |
Jerez de la Frontera, Spain | |
Contact: Angel León, Dr | |
Hospital Clínico Universitario Lozano Blesa | Recruiting |
Zaragoza, Spain | |
Contact: Luis Palomera, Dr | |
Hospital Universitario de Canarias | Recruiting |
Tenerife, Spain | |
Contact: Miguel Teodoro Hernández, Dr | |
Hospital Ramón y Cajal | Recruiting |
Madrid, Spain | |
Contact: Jose ´García Laraña, Dr | |
Hospital de la Princesa | Recruiting |
Madrid, Spain | |
Contact: Adrián Alegre, Dr | |
Hospital Clínico de Valencia | Recruiting |
valencia, Spain | |
Contact: A. I. Teruel, Dr | |
Hospital General Univeristario Morales Messeguer | Recruiting |
Murcia, Spain | |
Contact: Felipe de Arriba, Dr |
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 Clínic Barcelona |
Principal Investigator: | Juan José Lahuerta, Dr | Hospital Doce de Octubre |
Responsible Party: | Pethema ( Pethema ) |
Study ID Numbers: | 2007-000649-36, QUIREDEX |
Study First Received: | May 28, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00480363 History of Changes |
Health Authority: | Spain: Ministry of Health |
Smoldering Multiple Myeloma PETHEMA Smoldering |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Lenalidomide Disease Progression Vascular Diseases |
Antiemetics Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vascular Diseases Lenalidomide Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents |