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Trial record 23 of 372 for:    LENALIDOMIDE AND Dexamethasone

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

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ClinicalTrials.gov Identifier: NCT02918331
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab (16 mg/kg) Drug: Lenalidomide Drug: Dexamethasone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone (DRd) in Japanese Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Daratumumab with Lenalidomide and dexamethasone

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)
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.

Drug: Lenalidomide
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.

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




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone [ Time Frame: Cycle 1, Day 1 to Day 28 ]
    Number of Participants With Dose Limiting Toxicity During Cycle 1.


Secondary Outcome Measures :
  1. Rate of Complete Response (CR) or Better [ Time Frame: Approximately 3.7 years ]
    CR is Defined as the proportion of Participants achieving CR (including stringent complete response [sCR]) according to the International Myeloma Working Group (IMWG) criteria.

  2. Overall Response Rate (ORR) [ Time Frame: Approximately 3.7 years ]
    ORR is defined as the percentage of participants who achieve CR, Partial Response (PR), VGPR, and sCR according to the IMWG criteria, during or after study treatment.

  3. Very good partial response (VGPR) or better (VGPR, CR, or sCR) [ Time Frame: Approximately 3.7 years ]
    VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 pecent (%) reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram(mg)/24 hour (h).

  4. Minimum Observed Serum Concentration (Cmin) [ Time Frame: 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) ]
    The Cmin is the minimum observed analyte concentration.

  5. Maximum Observed Concentration (Cmax) [ Time Frame: 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) ]
    The Cmax is the maximum observed analyte concentration.

  6. Immunogenicity of daratumumab [ Time Frame: Cycle 1, Cycle 3, 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) ]
    Anti-daratumumab antibodies will be evaluated in serum samples collected for all the participants.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918331


Locations
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Japan
Hiroshima, Japan
Kanazawa, Japan
Nagoya, Japan
Osaka, Japan
Shibuya, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02918331     History of Changes
Other Study ID Numbers: CR108197
54767414MMY1006 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
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
Daratumumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal