Plasma Cell DisorderPhase 1/2NCT07075510
Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders
A Phase 1/2 study testing Daratumumab Injection in people with Plasma Cell Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Disorder
- What is being tested?
- Daratumumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 1 Oct 2032
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of MM (newly diagnosed or relapsed) or AL amyloid with planned therapy with daratumumab-based regimen. and has not received daratumumab previously or has received daratumumab > 6 months prior to planned Cycle 1 Day 1 alone or in combination with other regimens per investigator discretion.
- Provide signed written informed consent
- 18 years or older (at the time consent is obtained)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with a history of autologous stem cell transplant or prior CAR-T cell therapy can enroll on the study provided that:
- Therapy was >100 days prior to study enrollment
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- No active infection(s)
- Adequate organ system function
- Female participants: Contraceptive use for those participating in clinical studies (men or women) should be consistent with local regulations: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP) OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.
- We will review the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a new undetected pregnancy.
- Non childbearing potential is defined as follows (by other than medical reasons):
- ≥45 years of age and has not had menses for >1 year
- Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
- Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
- Refrain from donating sperm PLUS either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
- Must agree to use contraception/barrier and use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential
- All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy.
- Participants are able to comply with visit schedule and agree to weekly visits for 9 weeks
Who cannot join
- Systemic anti-myeloma therapy within ≤14 days or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to the first dose of study drug
- Systemic treatment with high dose steroids (equivalent to >60 mg prednisone daily for ≥4 days) within the past 14 days if administered to treat MM or non- MM disease
- Evidence of active bleeding
- Any major surgery within the last 28 days
- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided participants fulfil entry criteria (as defined by inclusion criteria #6)
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere participants' safety, obtaining informed consent or compliance with study procedures.
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- Current unstable liver disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
- Other malignancies are excluded, except for malignancy from which the patients have been disease-free for more than 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, prostate cancer or in situ cervical or breast cancer that has undergone potentially curative 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 (see Attachment XX), or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
- History of cardiovascular disease including any of the following:
- History of clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block.
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of screening.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system.
- Uncontrolled hypertension.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to daratumumab
- Active infection requiring treatment.
- Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb), at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody positivity as the only serologic marker (HBsAb) indicating previous vaccination will not exclude a participant provided that patient has a known history of prior HBV vaccination Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
- Pregnant or lactating female
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
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Ashraf Badros, MD
About this study
Official title: A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders
The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Read more
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson \& Johnson Innovative Medicine (J\&J IM).
- Conditions
- Plasma Cell Disorder
- Being tested
- Daratumumab Injection
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab InjectionDrug
Daratumumab Administration in the Anterior Upper Thigh versus the Abdomen
| Study group | Role | What they receive |
|---|---|---|
| ArmA: Treatment with Subcutaneous Daratumumab Administration in the Anterior Upper Thigh | Experimental | Treatment will be given for 8 weeks. SC Daratumumab will be administered in the thigh weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen Receives: Drug: Daratumumab Injection |
| ArmB: Treatment with Subcutaneous Daratumumab Administration in the Abdomen | Active comparator | Treatment will be given for 8 weeks. SC Daratumumab will be administered in the abdomen weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen Receives: Drug: Daratumumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To characterize the safety and tolerability of subcutaneous daratumumab administered in the thigh vs the abdomen in patients with plasma cell disorders.
Frequency and incidence rate of adverse events by type, severity, timing, and attribution to study drug, according to the NCI-CTCAE version 5.0.
Measured: Time of first dose (week 1), up to 8 doses (week 9)
Secondary outcomes (1)
Measure of maximum serum trough concentration of daratumumab [Pharmacokinetic (PK) Analysis]
To assess serum concentrations of daratumumab administered in the thigh vs the abdomen in patients with plasma cell disorders.
To measure maximum serum trough concentration of daratumumab, defined as the pre-dose serum concentration of daratumumab on Week 9, Day 1 (after 8 weekly doses)
Measured: Time of first dose (week 1), up to 8 doses (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start23 Oct 2025
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plasma Cell DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Ashraf Badros, MD, Principal investigator, University of Maryland, Baltimore Greenebaum Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075510
- Sponsor's protocol ID
- 2513GCCC
- Other IDs
- HP-00113670
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23.
PubMed 32213342Mateos M-V, Usmani SZ, Grosicki S, et al. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Body Weight Subgroup Analysis of Columba. Blood. 2019;134(Supplement 1):1906. doi:10.1182/blood-2019-122501
Usmani SZ, Mateos M-V, Nahi H, et al. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients with Relapsed or Refractory Multiple Myeloma: Columba Update. Blood. 2019;134(Supplement 1):1865. doi:10.1182/blood-2019- 122765
Zou P, Wang F, Wang J, Lu Y, Tran D, Seo SK. Impact of injection sites on clinical pharmacokinetics of subcutaneously administered peptides and proteins. J Control Release. 2021 Aug 10;336:310-321. doi: 10.1016/j.jconrel.2021.06.038. Epub 2021 Jun 26.
PubMed 34186147Reinisch M, Untch M, Mahlberg R, Reimer T, Hitschold T, Marme F, Aydogdu M, Schmatloch S, Luck HJ, Schmidt M, Ladda E, Sinn BV, Klare P, Janni W, Jackisch C, Denkert C, Seiler S, Gohler T, Michel L, Burchardi N, Stickeler E, Rey J, Klutinus N, Mobus V, Loibl S. Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study. Breast. 2022 Dec;66:110-117. doi: 10.1016/j.breast.2022.10.002. Epub 2022 Oct 5.
PubMed 36223695
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders
- ClinicalTrials.gov ID
- NCT07075510
- Acronym / sponsor ID
- 2513GCCC
- Conditions
- Plasma Cell Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 20 Jul 2025 (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.
The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson \& Johnson Innovative Medicine (J\&J IM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArmA: Treatment with Subcutaneous Daratumumab Administration in the Anterior Upper Thigh | Experimental | Drug: Daratumumab InjectionTreatment will be given for 8 weeks. SC Daratumumab will be administered in the thigh weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen |
| ArmB: Treatment with Subcutaneous Daratumumab Administration in the Abdomen | Active comparator | Drug: Daratumumab InjectionTreatment will be given for 8 weeks. SC Daratumumab will be administered in the abdomen weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically confirmed diagnosis of MM (newly diagnosed or relapsed) or AL amyloid with planned therapy with daratumumab-based regimen. and has not received daratumumab previously or has received daratumumab > 6 months prior to planned Cycle 1 Day 1 alone or in combination with other regimens per investigator discretion.
- Provide signed written informed consent
- 18 years or older (at the time consent is obtained)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with a history of autologous stem cell transplant or prior CAR-T cell therapy can enroll on the study provided that:
Key exclusion criteria (19 listed)
- Systemic anti-myeloma therapy within ≤14 days or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to the first dose of study drug
- Systemic treatment with high dose steroids (equivalent to >60 mg prednisone daily for ≥4 days) within the past 14 days if administered to treat MM or non- MM disease
- Evidence of active bleeding
- Any major surgery within the last 28 days
- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided participants fulfil entry criteria (as defined by inclusion criteria #6)
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 InjectionDaratumumab Administration in the Anterior Upper Thigh versus the Abdomen | Drug | ArmA: Treatment with Subcutaneous Daratumumab Administration in the Anterior Upper Thigh, ArmB: Treatment with Subcutaneous Daratumumab Administration in the Abdomen |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Time of first dose (week 1), up to 8 doses (week 9)
To characterize the safety and tolerability of subcutaneous daratumumab administered in the thigh vs the abdomen in patients with plasma cell disorders. Frequency and incidence rate of adverse events by type, severity, timing, and attribution to study drug, according to the NCI-CTCAE version 5.0.
1 secondary outcome
Measure of maximum serum trough concentration of daratumumab [Pharmacokinetic (PK) Analysis]
Time frame: Time of first dose (week 1), up to 8 doses (week 9)
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 29 Oct 2026.
- Background: PubMed 32213342Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23.
- BackgroundMateos M-V, Usmani SZ, Grosicki S, et al. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Body Weight Subgroup Analysis of Columba. Blood. 2019;134(Supplement 1):1906. doi:10.1182/blood-2019-122501
- BackgroundUsmani SZ, Mateos M-V, Nahi H, et al. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients with Relapsed or Refractory Multiple Myeloma: Columba Update. Blood. 2019;134(Supplement 1):1865. doi:10.1182/blood-2019- 122765
- Background: PubMed 34186147Zou P, Wang F, Wang J, Lu Y, Tran D, Seo SK. Impact of injection sites on clinical pharmacokinetics of subcutaneously administered peptides and proteins. J Control Release. 2021 Aug 10;336:310-321. doi: 10.1016/j.jconrel.2021.06.038. Epub 2021 Jun 26.
- Background: PubMed 36223695Reinisch M, Untch M, Mahlberg R, Reimer T, Hitschold T, Marme F, Aydogdu M, Schmatloch S, Luck HJ, Schmidt M, Ladda E, Sinn BV, Klare P, Janni W, Jackisch C, Denkert C, Seiler S, Gohler T, Michel L, Burchardi N, Stickeler E, Rey J, Klutinus N, Mobus V, Loibl S. Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study. Breast. 2022 Dec;66:110-117. doi: 10.1016/j.breast.2022.10.002. Epub 2022 Oct 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ashraf Badros, MD principal investigator
University of Maryland, Baltimore Greenebaum Comprehensive 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 1/2 study testing Daratumumab Injection in people with Plasma Cell Disorder, run by University of Maryland, Baltimore 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 24 inclusion and 19 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 29 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sunita Philip (410-328-8199, sphilip1@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Time of first dose (week 1), up to 8 doses (week 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075510, which also lists 5 linked publications.
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 29 Oct 2026.