A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

NCT00928486 | Completed Phase 3 Results

• 1 other identifier: CC-5013-MM-022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

  A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)

  Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks

Secondary Outcomes (2)

• Myeloma Response Rate

  From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks

• Kaplan-Meier Estimates of Duration of Response (DoR)

  From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks

Study Arms (1)

Lenalidomide and Dexamethasone

EXPERIMENTAL

Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle

Also known as: CC-5013, Revlimid

Lenalidomide and Dexamethasone

Dexamethasone DRUG

Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle

Also known as: Decadron

Lenalidomide and Dexamethasone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must understand and voluntarily sign the informed consent form
• Age ≥ 20 years at the time of signing the informed consent form
• Subjects with previously treated multiple myeloma defined as follows:
• Subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and
• Considered to have progression of disease (PD) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study
• Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL \[5g/L\]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Must be able to adhere to the study visit schedule and other protocol requirements
• Females of childbearing potential (FCBP) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below:
• For at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).
• During the treatment phase (including the dose withholding period) For at least 28 days after the discontinuation/completion of the study drug (Methods of contraception)
• Birth control pills
• Intrauterine device (IUD)
• Bilateral tubal ligation (FCBP must be referred to a health care provider who is familiar with contraceptive methods, if needed).
• Male subject must agree to use a condom during sexual contact with female irrespective of pregnancy potential

You may not qualify if:

• Pregnant or lactating females
• Subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs
• Subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs
• Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
• Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
• Subjects with posterior subcapsular cataracts
• Subjects with peripheral neuropathy of ≥Grade 2
• Subjects with any history or concurrent conditions which the Principal Investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study.
• Subjects with a history of desquamative (blistering) rash while taking thalidomide
• Subjects with a history of using lenalidomide
• Subjects who have used thalidomide within 28 days before starting the study drugs
• Subjects with a history of hypersensitivity to dexamethasone
• Subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose dexamethasone
• Subjects with a surgical wound after a visceral surgery performed recently
• Subjects who have undergone radiation therapy within 14 days before starting the study drugs

Sponsors & Collaborators

• Celgene: lead

Study Sites (8)

Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, 951-5866, Japan

Location

Osaka Red Cross Hospital

Osaka, Osaka, 543-8555, Japan

Location

Tokushima University

Tokushima, Tokushima, 770-8503, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone; Calcium Dobesilate

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

1-888-260-1599

Study Officials

• Masaaki Takatoku, MD

  Celgene KK

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 26, 2009
• Study Start: April 28, 2009
• Primary Completion: September 10, 2010
• Study Completion: September 10, 2010
• Last Updated: November 20, 2019
• Results First Posted: June 14, 2016

Record last verified: 2019-11

Locations

JP (8)