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

Overview

About this study

The purpose of this study is to evaluate three different daratumumab dose schedules to treat participants who have Smoldering Multiple Myeloma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
  • Have a confirmed diagnosis of intermediate or high-risk SMM
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

 

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 investigational treatments for SMM and/or multiple myeloma
    • Daratumumab or other anti CD-38 therapies
    • Treatment with corticosteroids with a dose > 10 mg prednisone per day or equivalent 
    • Bone-protecting agents (eg, bisphosphonates, denosumab)  are only allowed if given in a stable dose and for a nonmalignant condition
    • Received an investigational drug (including investigational 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 of randomization, except for the following if treated and not active
    • Basal cell or nonmetastatic squamous cell carcinoma of the skin
    • Cervical carcinoma in situ
    • Ductal carcinoma in situ of the breast
    • International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
  • Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma 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 study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Asher Chanan-Khan, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20178004

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