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Could multiple myeloma patients get their infusions at home?

NCT ID NCT05511428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Nov 2022

Finished

May 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.