A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

NCT ID: NCT01698801

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-01
• Study Completion Date: 2018-06-26

Brief Summary

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide plus dexamethasone

Lenalidomide plus low-dose dexamethasone

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle

dexamethasone

Intervention Type: DRUG

40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Interventions

Lenalidomide

25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle

Intervention Type: DRUG

dexamethasone

40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Intervention Type: DRUG

Other Intervention Names

Revlimid; LenaDex

Eligibility Criteria

Inclusion Criteria

• Age ≥ 20 years at the time of signing the informed consent document
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
• Able to adhere to the study visit schedule and other protocol requirements
• Previously untreated, symptomatic multiple myeloma
• Have measurable disease by protein electrophoresis analyses
• At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Any condition that confounds the ability to interpret data from the study
• Previous treatment with anti-myeloma therapy
• Pregnant or lactating females
• Any of the following laboratory abnormalities:

• Absolute neutrophil count (ANC) < 1,000/microL (1.0 × 10^9/L )
• Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/microL (50 × 10^9/L)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal
• Renal failure requiring hemodialysis or peritoneal dialysis
• Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
• Subjects who are unable or unwilling to undergo antithrombotic therapy.
• Peripheral neuropathy of ≥ grade 2 severity.
• Uncontrolled systemic fungal, bacterial, or viral infection
• Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
• Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
• Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
• Ineligible for dexamethasone or dexamethasone is contraindicated.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toru Sasaki

Role: STUDY_DIRECTOR

Celgene K.K.

Locations

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Kameda Medical Center

Kamogawa, Chiba, Japan

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan

Ehime University Hospital

Touon, Ehime, Japan

Nishigunma National Hospital

Shibukawa, Gunma, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Iwate Medical University

Morioka, Iwate, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Kinki University Hospital, Faculty of Medicine

Sayama, Osaka, Japan

Shizuoka Cancer Center

Sunto, Shizuoka, Japan

National Disaster Medical Center

Tachikawa, Tokyo, Japan

Kagoshima Medical Center

Kagoshima, , Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Okayama Medical Center

Okayama, , Japan

Osaka Red Cross Hospital

Osaka, , Japan

National Cancer Center Hospital

Tokyo, , Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, , Japan

Japanese Red Cross Medical Center

Tokyo, , Japan

Keio University Hospital

Tokyo, , Japan

Countries

Japan

References

Suzuki K, Shinagawa A, Uchida T, Taniwaki M, Hirata H, Ishizawa K, Matsue K, Ogawa Y, Shimizu T, Otsuka M, Matsumoto M, Iida S, Terui Y, Matsumura I, Ikeda T, Takezako N, Ogaki Y, Midorikawa S, Houck V, Ervin-Haynes A, Chou T. Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study. Cancer Sci. 2016 May;107(5):653-8. doi: 10.1111/cas.12916. Epub 2016 Mar 30.

Reference Type: RESULT

PMID: 26914369 (View on PubMed)

Other Identifiers

CC-5013-MM-025

Identifier Type: -

Identifier Source: org_study_id