A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens


About this study

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

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:

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria.
  • Measurable, secretory disease as defined by any of the following:
    • Serum monoclonal paraprotein (M-protein) level greater than or equal to (≥) 1.0 gram per deciliter (g/dL); or
    • Urine M-protein level ≥ 200 milligram per 24 hours (mg/24 hours); or
    • Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) ≥ 10 mg/dL and abnormal FLC ratio.
  • Meets one of the sets of the following criteria:
    • For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma; or
    • For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2.
  • During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction.

Exclusion Criteria:

  • History of malignancy (other than MM) if all treatment of that malignancy was completed at least 2 years before registration and the participant has no evidence of disease (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
  • Exhibits clinical signs of meningeal involvement of MM.
  • Either of the following:
    • Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal; or
    • Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification.
  • Any of the following:
    • Known to be seropositive for human immunodeficiency virus; or
    • Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded; or
    • Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).

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

Sikander Ailawadhi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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