A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Last updated: April 24, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Multiple Myeloma

Red Blood Cell Disorders

Platelet Disorders

Treatment

daratumumab

Clinical Study ID

NCT02316106
CR106449
54767414SMM2001
2014-005139-14
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years

  • Have a confirmed diagnosis of intermediate or high-risk SMM, and an EasternCooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion

Exclusion Criteria:

  • Active multiple myeloma,requiring treatment as defined by the study protocol

  • Primary systemic AL (immunoglobulin light chain) amyloidosis

  • Prior or concurrent exposure to any of the following: approved or investigationaltreatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg,bisphosphonates, denosumab) or are only allowed if given in a stable dose and for anonmalignant condition, or received an investigational drug (includinginvestigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1

  • History of malignancy (other than SMM) within 3 years before the date ofrandomization, except for the following if treated and not active: basal cell ornonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ,ductal carcinoma in situ of breast, or International Federation of Gynecology andObstetrics (FIGO) Stage 1 carcinoma of the cervix

  • Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistentasthma within the past 2 years

  • Any concurrent medical or psychiatric condition or disease (eg, autoimmune disease,active systemic disease, myelodysplasia) that is likely to interfere with the studyprocedures or results, or that in the opinion of the investigator, would constitutea hazard for participating in this study

Study Design

Total Participants: 123
Treatment Group(s): 1
Primary Treatment: daratumumab
Phase: 2
Study Start date:
May 20, 2015
Estimated Completion Date:
June 03, 2024

Study Description

This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM [ie, early disease without any symptoms]). Participants will be randomized (assigned by chance) to one of 3 treatment groups (arm A [long intense], arm B [intermediate] and arm C [short intense]) to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. For participants in Arm A (long intense) and Arm B (intermediate), there is a possibility to extend treatment with IV daratumumab (Q8W) after the end of Cycle 20 if, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade >=3 treatment related toxicity, and at least stable disease has been achieved. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w). The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 7 years after the last participant enrolled receives a first dose of study drug. 'Disease assessment will be performed locally per Standard of Care.

Connect with a study center

  • Box Hill,
    Australia

    Site Not Available

  • Concord,
    Australia

    Site Not Available

  • Melbourne,
    Australia

    Site Not Available

  • Woodville South,
    Australia

    Site Not Available

  • Calgary, Alberta
    Canada

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

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    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

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    Montreal, Quebec
    Canada

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  • Brno,
    Czechia

    Site Not Available

  • Hradec Kralove,
    Czechia

    Site Not Available

  • Praha 2,
    Czechia

    Site Not Available

  • Lille,
    France

    Site Not Available

  • Nantes,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Pierre Benite,
    France

    Site Not Available

  • Rennes Cedex,
    France

    Site Not Available

  • Berlin,
    Germany

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  • Chemnitz,
    Germany

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  • Essen,
    Germany

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    Freiburg,
    Germany

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    Hamburg,
    Germany

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  • Heidelberg,
    Germany

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  • Mainz,
    Germany

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  • München,
    Germany

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  • Tuebingen,
    Germany

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  • Würzburg,
    Germany

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    Hadera,
    Israel

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  • Haifa,
    Israel

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  • Jerusalem,
    Israel

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    Nahariya,
    Israel

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  • Petah Tikva,
    Israel

    Site Not Available

  • Tel Aviv,
    Israel

    Site Not Available

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria San Martino di Genova

    Genova, 16132
    Italy

    Site Not Available

  • Università di Roma 'La Sapienza' - Ospedale Umberto 1°

    Roma, 00161
    Italy

    Site Not Available

  • A.O.Citta della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Amsterdam,
    Netherlands

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    Dordrecht,
    Netherlands

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  • Rotterdam,
    Netherlands

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  • Utrecht,
    Netherlands

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  • Nizhny Novgorod,
    Russian Federation

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  • Petrozavodsk,
    Russian Federation

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    Rostov-On-Don,
    Russian Federation

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  • Ryazan,
    Russian Federation

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    Samara,
    Russian Federation

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  • St-Petersburg,
    Russian Federation

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    Syktyvkar,
    Russian Federation

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  • Ankara,
    Turkey

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  • Antalya,
    Turkey

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  • Izmir,
    Turkey

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  • Samsun,
    Turkey

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  • Cardiff,
    United Kingdom

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    Leicester,
    United Kingdom

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    London,
    United Kingdom

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    Manchester,
    United Kingdom

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  • Nottingham,
    United Kingdom

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  • Southampton,
    United Kingdom

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  • Surrey,
    United Kingdom

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  • Little Rock, Arkansas
    United States

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    San Francisco, California
    United States

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    Fort Myers, Florida
    United States

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  • Jacksonville, Florida
    United States

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    St. Petersburg, Florida
    United States

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  • West Palm Beach, Florida
    United States

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  • Atlanta, Georgia
    United States

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    Indianapolis, Indiana
    United States

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  • Boston, Massachusetts
    United States

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  • Ann Arbor, Michigan
    United States

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  • Saint Louis, Missouri
    United States

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    St. Louis, Missouri
    United States

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  • Hackensack, New Jersey
    United States

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  • New York, New York
    United States

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  • Chapel Hill, North Carolina
    United States

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  • Cincinnati, Ohio
    United States

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  • Columbus, Ohio
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

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