A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation

NCT02918331 | Completed Phase 1

• 2 other identifiers: CR10819754767414MMY1006
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone

  Number of Participants With Dose Limiting Toxicity During Cycle 1.

  Cycle 1, Day 1 to Day 28

Secondary Outcomes (6)

• Rate of Complete Response (CR) or Better

  Approximately 3.7 years

• Overall Response Rate (ORR)

  Approximately 3.7 years

• Very good partial response (VGPR) or better (VGPR, CR, or sCR)

  Approximately 3.7 years

• Minimum Observed Serum Concentration (Cmin)

  Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose)

• Maximum Observed Concentration (Cmax)

  Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose)

Study Arms (1)

Daratumumab with Lenalidomide and dexamethasone

EXPERIMENTAL

Daratumumab (16 milligram per kilogram \[mg/kg\]) will be administered by intravenous \[IV\] infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants will receive dexamethasone 40mg weekly, at day 1, 8, 15, 22 of each cycle.

Drug: Daratumumab (16 mg/kg); Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Daratumumab (16 mg/kg) DRUG

Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.

Daratumumab with Lenalidomide and dexamethasone

Lenalidomide DRUG

Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours.

Daratumumab with Lenalidomide and dexamethasone

Dexamethasone DRUG

Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle.

Daratumumab with 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:

• Participants with documented multiple myeloma (MM) satisfying the CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities) criteria , monoclonal plasma cells in the bone marrow more than equal to (\>=) 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable disease Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G MM: serum monoclonal paraprotein (M protein) level \>=1.0 gram/deciliter (dL) or urine M protein level \>= 200 milligram(mg)/24 hours; or (b) IgA, IgM, IgD, or IgE MM: serum M protein level \>=0.5 g/dL or urine M protein level \>=200 mg/24 hours; or (c) Light chain MM without measurable disease in serum or urine: serum Ig free light chain (FLC) \>=10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
• Participants newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to being \>=65 years old, or in subjects less than (\<) 65 years old presence of important comorbid condition(s) likely to have a negative effect on the tolerability of high-dose chemotherapy with ASCT
• Pretreatment clinical laboratory values meeting the following criteria during the Screening Phase
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 4 weeks prior to dosing and the second within 3 days prior to dosing

You may not qualify if:

• Participants with diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering MM
• Participant with plasma cell leukemia or other conditions in which Ig (immunoglobulin) M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
• Participants who have prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
• Participants with history of malignancy (other than MM) within 5 years before the date of the first daratumumab administration
• Participants who have radiation therapy within 14 days of the first dose

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (5)

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Kanazawa, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Shibuya City, Japan

Location

Related Publications (1)

• Takamatsu H, Iida S, Shibayama H, Shibayama K, Yamazaki H, Suzuki K. Daratumumab, lenalidomide, and dexamethasone in Japanese patients with transplant-ineligible newly diagnosed multiple myeloma: a phase 1b study. Int J Hematol. 2020 May;111(5):692-701. doi: 10.1007/s12185-020-02825-w. Epub 2020 Jan 30.

  PMID: 32002821 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; 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

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

JP (5)