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

NCT01698801 | Completed Phase 2 Results DMC

• 1 other identifier: CC-5013-MM-025
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 24

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

Keywords

Lenalidomide; dexamethasone; newly diagnosed multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

  From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.

Secondary Outcomes (5)

• Time to Response

  From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.

• Duration of Response

  From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.

• Progression Free Survival (PFS)

  From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.

• Overall Survival (OS)

  From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months

• Number of Participants With Adverse Events

  From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks

Study Arms (1)

Lenalidomide plus dexamethasone

EXPERIMENTAL

Lenalidomide plus low-dose dexamethasone

Drug: Lenalidomide; Drug: dexamethasone

Interventions

Lenalidomide DRUG

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

Also known as: Revlimid

Lenalidomide plus dexamethasone

dexamethasone DRUG

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

Also known as: LenaDex

Lenalidomide plus dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Celgene: lead

Study Sites (24)

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Kameda Medical Center

Kamogawa, Chiba, 296-8602, Japan

Location

Japanese Red Cross Narita Hospital

Narita, Chiba, 286-8523, Japan

Location

Ehime University Hospital

Touon, Ehime, 791-0295, Japan

Location

Nishigunma National Hospital

Shibukawa, Gunma, 377-8511, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Hitachi General Hospital

Hitachi, Ibaraki, 317-0077, Japan

Location

Iwate Medical University

Morioka, Iwate, 020-8505, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Kinki University Hospital, Faculty of Medicine

Sayama, Osaka, 589-8511, Japan

Location

Shizuoka Cancer Center

Sunto, Shizuoka, 411-8777, Japan

Location

National Disaster Medical Center

Tachikawa, Tokyo, 190-0014, Japan

Location

Kagoshima Medical Center

Kagoshima, 892-0853, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama Medical Center

Okayama, 701-1192, Japan

Location

Osaka Red Cross Hospital

Osaka, 543-8555, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, 135-8550, Japan

Location

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Related Publications (1)

• 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.

  PMID: 26914369 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; 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

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

Results Point of Contact

• Title: Senior Manager, Clinical Trials Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

1-888-260-1599

Study Officials

• Toru Sasaki

  Celgene K.K.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: October 1, 2012
• Primary Completion: November 26, 2013
• Study Completion: June 26, 2018
• Last Updated: November 8, 2018
• Results First Posted: December 3, 2014

Record last verified: 2018-10

Locations

JP (24)