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

NCT00480363 | Completed Phase 3 DMC

• 2 other identifiers: 2007-000649-36QUIREDEX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 13

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

Conditions

Multiple Myeloma

Keywords

Smoldering Multiple Myeloma; PETHEMA; Smoldering

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluate the efficacy of the treatment in response rate terms

  one year

• Evaluate the safety and tolerability of the treatment

  one year

Study Arms (2)

1

EXPERIMENTAL

Lenalidomide + Dexamethasone for 9 cycles and maintenance

Procedure: Maintenance with lower doses of lenalidomide and dexamethasone

2

NO INTERVENTION

Observation

Interventions

Maintenance with lower doses of lenalidomide and dexamethasone PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 has received other investigational drugs within 30 days before enrolment.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Celgene Corporation: collaborator

Study Sites (13)

Hospital germans Trias i Pujol

Badalona, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del SAS de Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital de la Princesa

Madrid, Spain

Location

Hospital Dode de Octubre

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital General Univeristario Morales Messeguer

Murcia, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Clínico de Valencia

Valencia, Spain

Location

Hospital Universitario la Fe

Valencia, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (32)

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• Davies FE, Raje N, Hideshima T, Lentzsch S, Young G, Tai YT, Lin B, Podar K, Gupta D, Chauhan D, Treon SP, Richardson PG, Schlossman RL, Morgan GJ, Muller GW, Stirling DI, Anderson KC. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood. 2001 Jul 1;98(1):210-6. doi: 10.1182/blood.v98.1.210.

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  BACKGROUND

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Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma

Interventions

Maintenance; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2007
• First Posted: May 30, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

ES (13)