Multiple MyelomaPhase 2NCT07485647
Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
A Phase 2 study testing Daratumumab and Recombinant Human Hyaluronidase and Lenalidomide in people with Multiple Myeloma, run by Eden Biltibo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab and Recombinant Human Hyaluronidase and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Eden Biltibo
Eden Biltibo
About this study
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.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab and Recombinant Human Hyaluronidase, Lenalidomide
- Keywords
- ASCT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab and Recombinant Human HyaluronidaseDrug
Also called Darzalex Faspro
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.
LenalidomideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab + Lenalidamide | Experimental | subcutaneous Q8W/Q16W daratumumab maintenance therapy in combination with lenalidomide with a historical cohort that used lenalidomide/Q4W daratumumab maintenance therapy Receives: Drug: Daratumumab and Recombinant Human Hyaluronidase; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with minimal residual disease (MRD) negative status
Determined by next generation sequencing or color flow cytometry per Euroflow standard procedure at sensitivity threshold of 10^-5.
Measured: 2 years
Secondary outcomes (3)
Assess MRD dynamics at enrollment, day + 365 and at 2 years, including rate of sustained MRD negativity.
Measured: At enrollment, day + 365 and at 2 years
Progression-free Survival (PFS) measured from day + 100 post-ASCT.
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.
Measured: 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.
Using Functional Assessment of Cancer Therapy-G item. Descriptive analysis will be used to summarize the changes.
Measured: At baseline, cycle 13 day 1, cycle 25 day 1, cycle 37 day 1 and at day 28 follow up (cycle length = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eden Biltibo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eden Biltibo, Vanderbilt-Ingram Cancer Center
- Investigators
- Eden Biltibo, MD, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485647
- Sponsor's protocol ID
- VICC-VCPCL23547
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
- ClinicalTrials.gov ID
- NCT07485647
- Acronym / sponsor ID
- VICC-VCPCL23547
- Conditions
- Multiple Myeloma
- Keywords
- ASCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eden BiltiboUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daratumumab + Lenalidamide | Experimental | Drug: Daratumumab and Recombinant Human Hyaluronidase, Drug: Lenalidomidesubcutaneous Q8W/Q16W daratumumab maintenance therapy in combination with lenalidomide with a historical cohort that used lenalidomide/Q4W daratumumab maintenance therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daratumumab and Recombinant Human HyaluronidaseAlso: Darzalex FasproDaratumumab- 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. | Drug | Daratumumab + Lenalidamide |
| LenalidomidePatients 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 | Drug | Daratumumab + Lenalidamide |
Primary outcome
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.
3 secondary outcomes
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eden Biltibo, MD, PhD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab and Recombinant Human Hyaluronidase and Lenalidomide in people with Multiple Myeloma, run by Eden Biltibo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Service Information Program (800-811-8480, cip@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with minimal residual disease (MRD) negative status (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.