Could multiple myeloma patients get their infusions at home?
NCT ID NCT05511428
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving Darzalex Faspro (a drug for multiple myeloma) at home is practical and satisfactory for patients. Twenty adults with multiple myeloma who were already on a monthly daratumumab regimen received their injections at home. The main goal was to measure treatment satisfaction using a questionnaire. The study also tracked how well patients stuck to their home treatment schedule.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Daratumumab and hyaluronidase (Darzalex Faspro)
- What this could lead to
- If successful, this could show that giving multiple myeloma treatment at home is safe and satisfactory, reducing the need for frequent hospital visits.
- What could go wrong
- This was a very small study (20 people) with no comparison group, so results may not apply to everyone. It focused on satisfaction, not on whether the drug works better or worse at home.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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20 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, aged greater than 18 years of age * Has a diagnosis of Multiple Myeloma * Is on the monthly phase of daratumumab (either intravenous \[IV\] or subcutaneous \[SubQ\]) based regimen (every 4 weeks) (either monotherapy or in combination with oral agents) * Is willing to receive daratumumab subcutaneous injections * Lives within the range of Jefferson Home Infusion Services * Patients are willing to allow home infusion company visit them and administer Darzalex-Faspro in the home * Women of reproductive potential must use highly effective contraception * Men of reproductive potential must use highly effective contraception * Absolute neutrophil count (ANC) \> 1,000 * Platelet count \> 50,000 * Aspartate aminotransferase (AST) / alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 2 times ULN * Creatinine clearance (CrCl) \>= 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide \>= 30 mL/min * English speaking Exclusion Criteria: * Receiving daratumumab for an indication other than multiple myeloma * Receiving daratumumab in combination with other IV or subcutaneous therapy * Pregnancy or lactation * Known allergic reactions to components of the study product(s) * Uncontrolled human immunodeficiency virus (HIV) * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]) who are not on hepatitis B prophylaxis. Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive and not on Hep B prophylaxis will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV deoxyribonucleic acid (DNA) by PCR * Patients with reactivation of hepatitis B will be excluded * Seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as a viremia at least 12 weeks after completion of antiviral therapy) * Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \< 50% of predicted normal * Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate * Clinically significant cardiac disease, including: * Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) * Uncontrolled cardiac arrhythmia * Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Fridericia's formula \> 470 msec * Non-English Speaking
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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