Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
United States50 participantsStarted 2026-05
Plain-language summary
This phase II trial tests daratumumab given at a reduced frequency with lenalidomide for maintenance therapy for the cost effective treatment of patients with multiple myeloma post stem cell transplant. Darzalex Faspor (also known as Daratumumab-hyaluronidase) is a combination of two drugs used alone or with other drugs to treat adults with certain types of multiple myeloma or light chain amyloidosis. Daratumumab binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase allows daratumumab to be given by injection under the skin. Daratumumab and hyaluronidase can be given in less time than daratumumab alone, which is given as an infusion. Lenalidomide may stop or slow cancer cells by blocking the growth of new blood vessels necessary for tumor growth. Daratumumab-hyaluronidase is typically given every 4 weeks per standard of care. Giving it every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide may be equally as effective and reduce costs and treatment visits for patients with multiple myeloma post stem cell transplant.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed and dated written informed consent
* Male or female newly diagnosed multiple myeloma (NDMM) patients 18 to 70 years old on the day of signing informed consent who had ASCT with post-ASCT response of partial response (PR) or better as defined by International Myeloma Working Group (IMWG). The induction regimen should include a proteasome inhibitors (PI), immunomodulatory drugs (IMiD) and anti-CD38 monoclonal antibody
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients with high-risk and international staging system (ISS) stage-III disease in 15% of the intent to treat population. Patients with 1q gain, 1p deletion, del17p, t\[4;14\], or t\[14;16\] by fluorescence in situ hybridization \[FISH\] will be categorized as having high risk disease
* Absolute neutrophil count, ≥ 1.0 × 10\^9/L
* Platelets ≥ 75,000/μL
* Hemoglobin level ≥ 7.5 g/dL
* Total bilirubin \< 1.5 times institutional upper limit of normal (ULN) (if patient has known history of Gilbert's syndrome, total bilirubin will not be used as an exclusion criteria)
* Corrected serum calcium, ≤ 14.0 mg/dL (≤ 3.5 mmol/L)
* Platelet count, ≥ 50 × 10\^9/L (≥ 50 × 10\^9/L if ≥ 50% of the bone marrow was infiltrated with multiple myeloma \[MM\] cells)
* Alanine aminotransferase and aspartate aminotransferase levels \< 2.5 times the upper limit of normal
* Creatinine clearance ≥ 30 mL/min (per institutional standard)
* All ASCT-related toxicities must have recovered to…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with minimal residual disease (MRD) negative status