Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma

This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King Faisal Specialist Hospital &Reseach Center

Riyadh, 11211, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients must have newly diagnosed multiple myeloma
Patients must have received no prior chemotherapy for this disease. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration. Patients must not have received any prior treatment with bortezomib or lenalidomide.
Patients must be ≥ 18 years of age at the time of registration.
Patients must have a Zubrod Performance Status (PS) of 0 - 3
Patients must have adequate marrow function as defined herein:
Platelet count ≥ 80 x 103/mcL,
ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
Institutions must submit a local cytogenetics report and FISH analysis report
Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
Patients must have a calculated or measured creatinine clearance > 30 cc/min.
Patients must not have uncontrolled, active infection requiring intravenous antibiotics
Patients must not have any psychiatric illness
Patients must not be Hepatitis B, Hepatitis C or HIV positive
Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
Patients must be able to take aspirin 325 mg daily
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.

Treatment and study plan

Lenalidomide/Low dose Dex

Drug

Lenalidomide/Low dose Dex (LLD)

Bortezomib/Lenalidomide/ Low dose Dex

Drug

Bortezomib/Lenalidomide/ Low dose Dex (BLLD)

Lenalidomide

Drug

Lenalidomide/Low dose Dex (LLD

Primary outcomes

comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone

Time frame: Four years

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Feb 10, 2012
Registry last updated: Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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