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

This study is currently recruiting participants.

Verified February 2012 by King Faisal Specialist Hospital & Research Center

Sponsor:

Information provided by (Responsible Party):

King Faisal Specialist Hospital & Research Center

ClinicalTrials.gov Identifier:

NCT01530594

First received: January 23, 2012

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Lenalidomide/Low dose Dex Drug: Bortezomib/Lenalidomide/ Low dose Dex Drug: Lenalidomide	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Bortezomib Lenalidomide

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	440
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lenalidomide Lenalidomide/Low dose Dex (LLD)	Drug: Lenalidomide/Low dose Dex Lenalidomide/Low dose Dex (LLD) Drug: Lenalidomide Lenalidomide/Low dose Dex (LLD
Experimental: Bortezomib/Lenalidomide Bortezomib/Lenalidomide/ Low dose Dex (BLLD)	Drug: Bortezomib/Lenalidomide/ Low dose Dex Bortezomib/Lenalidomide/ Low dose Dex (BLLD)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530594

Locations

Saudi Arabia
King Faisal Specialist Hospital &Reseach Center	Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Naeem Chaudri, MD 966) 01- 442-32019 chaudhri@kfshrc.edu.sa

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

More Information

No publications provided

Responsible Party:	King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:	NCT01530594 History of Changes
Other Study ID Numbers:	2081-113
Study First Received:	January 23, 2012
Last Updated:	February 9, 2012
Health Authority:	United States: Federal Government Saudi Arabia: Ethics Committee

Keywords provided by King Faisal Specialist Hospital & Research Center:

Untreated
Without intent for immediate autologous stem cell transplant

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

Bortezomib
Lenalidomide
Thalidomide
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 22, 2013

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