Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

August 17, 2026 updated by: Eden Biltibo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Vanderbilt-Ingram Service Information Program
  • Phone Number: 800-811-8480
  • Email: cip@vanderbilt.edu

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Eden Biltibo
        • Principal Investigator:
          • Eden Biltibo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 ≤ grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization
  • Mucositis and gastrointestinal symptoms must have resolved to ≤ grade 1
  • Patients must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All patients of childbearing potential must have a negative test result via blood test or urine study with a sensitivity of at least 50 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. Patients of childbearing potential must also agree to ongoing pregnancy testing while on treatment. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * 1) has achieved menarche at some point, * 2) has not undergone a hysterectomy or bilateral oophorectomy, or * 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Patients of childbearing potential must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for * 1) at least 28 days before starting study treatment; * 2) while participating in the study; * 3) during dose interruptions; and * 4) for at least 3 months after the last dose of protocol treatment. Patients must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a partner of childbearing potential while participating in the study and for 3 months after the last dose of lenalidomide even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or eggs while on study treatment and for 3 months after the last dose of protocol. Patients must agree to abstain from donating blood during study participation and for at least 28 days after last dose of lenalidomide

Exclusion Criteria:

  • All patients with concomitant amyloidosis or plasma cell leukemia
  • Patient is pregnant or breastfeeding
  • Has received a live vaccine within 30 days prior to first dose of study treatment. * Examples of prohibited live vaccines include but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccine. * Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (for example FluMist® Quadrivalent [Influenza Vaccine Live, Intranasal, MedImmune]) are live attenuated vaccines and are not allowed. COVID-19 vaccines that are messenger ribonucleic acid (mRNA) based which do not use live virus are allowed
  • Is currently participating in or within 4 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device. * Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose or last exposure to the previous investigational agent or investigational device
  • Diagnosis of immunodeficiency; or is receiving systemic steroid therapy exceeding 10 mg daily prednisone equivalent dose (=10mg is acceptable); or has received any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to first dose of study treatment. * Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, in situ cervical cancer or breast carcinoma, superficial bladder cancer, or carcinoma in situ of the prostate) that have undergone potentially curative therapy are not excluded
  • Radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator and radiology review
  • Recipient of previous allogeneic tissue/solid organ transplant
  • Known severe hypersensitivity (≥ grade 3) to drug daratumumab or lenalidomide
  • History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including transient ischemic attack [TIA]) within the past 6 months (24 weeks) prior to starting study treatment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, or psychiatric illness/social situations that would limit compliance with study requirements
  • Active autoimmune disease with immunodeficiency as a clinical component (for example, rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing spondylitis)
  • Recognized immunodeficiency disease including cellular immunodeficiencies; hypogammaglobulinemia or dysgammaglobulinemia; or acquired, hereditary, or congenital immunodeficiencies
  • Known conditions associated with immunosuppression such as uncontrolled HIV/AIDS, leukemia, lymphoma, generalized malignancy, solid organ transplant recipient, or allogeneic hematopoietic stem cell transplant recipient
  • Gastrointestinal disease that may significantly alter the absorption of oral drugs
  • Unable or unwilling to undergo antithrombotic prophylactic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daratumumab + Lenalidamide
subcutaneous Q8W/Q16W daratumumab maintenance therapy in combination with lenalidomide with a historical cohort that used lenalidomide/Q4W daratumumab maintenance therapy
Drug: Daratumumab and Recombinant Human Hyaluronidase
Daratumumab- will be administered at a dose of 1800 mg/30,000 units subcutaneously, every 8 weeks throughout Year 1 (injection to occur on day 1 of every other 28-day cycle for Cycle 1 through Cycle 11); throughout years 2 through 4 (beginning at Cycle 15, ending at Cycle 47), Daratumumab injections will occur every fourth cycle.
Other Names:
  • Darzalex Faspro
Drug: Lenalidomide
Patients are scheduled to take an oral dose of Lenalidomide once each day (QD), starting at 10 mg per day for the first 3 months with an increase to 15 mg per day subsequently, if tolerated. Patients will do this continuously, until progressive disease or unacceptable adverse event

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with minimal residual disease (MRD) negative status
Time Frame: 2 years
Determined by next generation sequencing or color flow cytometry per Euroflow standard procedure at sensitivity threshold of 10^-5.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess MRD dynamics at enrollment, day + 365 and at 2 years, including rate of sustained MRD negativity.
Time Frame: At enrollment, day + 365 and at 2 years
At enrollment, day + 365 and at 2 years
Progression-free Survival (PFS) measured from day + 100 post-ASCT.
Time Frame: From day + 100 post-autologous stem cell transplant, up to 6 months post treatment
Noninferiority will be assessed by estimating the two-sided 95% confidence interval for the between-group difference in crude rates of 2-year progression-free survival and checking that the lower bound was not lower than -10%. Will conduct the analysis of progression-free survival by using Kaplan-Meier survival curves.
From day + 100 post-autologous stem cell transplant, up to 6 months post treatment
Assess patient satisfaction on treatment arm using Functional Assessment of Cancer Therapy (FACT)-G item.
Time Frame: At baseline, cycle 13 day 1, cycle 25 day 1, cycle 37 day 1 and at day 28 follow up (cycle length = 28 days)
Using Functional Assessment of Cancer Therapy-G item. Descriptive analysis will be used to summarize the changes.
At baseline, cycle 13 day 1, cycle 25 day 1, cycle 37 day 1 and at day 28 follow up (cycle length = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eden Biltibo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eden Biltibo, MD, PhD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VICC-VCPCL23547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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