A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

Key facts

Study ID

NCT03277105

Run by

Janssen Research & Development, LLC

People needed

522

Starts

2017-10-27

Expected to finish

2024-01-12

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
• Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
• Documented multiple myeloma as defined by the criteria below:
• Multiple myeloma diagnosis according to the IMWG diagnostic criteria
• Measurable disease at Screening as defined by any of the following:
• Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
• Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Meet the clinical laboratory criteria as specified in the protocol
• Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

You may not qualify if…

• Received daratumumab or other anti-CD38 therapies previously
• Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
• Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
• Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
• History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further 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

Where it is running

• Levine Cancer Institute — Charlotte, North Carolina, United States
• Royal Prince Alfred Hospital — Camperdown, Australia
• St Vincents Hospital Melbourne — Fitzroy, Australia
• Alfred Health — Melbourne, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• Calvary Mater Newcastle Hospital — Waratah, Australia
• The Queen Elizabeth Hospital — Woodville South, Australia
• Princess Alexandra Hospital — Woolloongabba, Australia
• Fundacao Pio XII — Barretos, Brazil
• Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN — Florianópolis, Brazil
• Fundacao Doutor Amaral Carvalho — Jaú, Brazil
• Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia — Joinville, Brazil
• Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo — Passo Fundo, Brazil
• Hospital das Clinicas de Porto Alegre — Porto Alegre, Brazil
• Instituto de Educacao, Pesquisa e Gestao em Saude — Rio de Janeiro, Brazil
• CEHON — Salvador, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base — São José do Rio Preto, Brazil
• Clinica Sao Germano — São Paulo, Brazil
• Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo, Brazil
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• The Gordon & Leslie Diamond Health Care Center — Vancouver, British Columbia, Canada
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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