A Phase 3 interventional study of Daratumumab SC: daratumumab + rHuPH20 in Smoldering Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Completed at 163 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
Among 71 studies in Smoldering Multiple Myeloma with a site in United States — 20 open to participants now, 34 under way, 4 of them phase 3. Smoldering Multiple Myeloma · United States.
Among the 71 studies in Smoldering Multiple Myeloma with a site in United States, this one is the 2nd largest by enrollment of the 56 interventional ones that give a count, is one of 6 that started in 2017, is one of 5 in phase 3, and was the 38th registered.
101 studies on the registry are indexed under Smoldering Multiple Myeloma; 34 are open to participants now.
Browse Smoldering Multiple Myeloma studies →20 of the 71 studies in Smoldering Multiple Myeloma with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States, France, Japan and 3 more countries
Ages 18+
University of Miami · Sites in United States
Ages 18+
Wake Forest University Health Sciences · Sites in United States
Ages 30+ · Healthy volunteers
Janssen Research & Development, LLC · Sites in United States, Australia, Israel and 2 more countries
Ages 18+
Regeneron Pharmaceuticals · Sites in United States, Belgium, France and 4 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Smoldering Multiple Myeloma studies recruiting now, 27 (90%) set no upper age limit and 1 (3%) stops at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
71 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 32 · Phase 3 5
First in 2003; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 390 is above the median of 31 across 71 interventional studies indexed under Smoldering Multiple Myeloma.
Median enrollment 30 across the 56 interventional studies, 400 across the 15 observational. Of the 32 that completed or were terminated, 23 (72%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 71 have an industry lead sponsor. The 10 most frequent:
This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Johnson & Johnson has 5 studies filed under Smoldering Multiple Myeloma — fewer than ten, so there is no comparison to draw.
10 of the studies in Smoldering Multiple Myeloma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05640843Memorial Sloan Kettering Cancer CenterA Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) | 2026-11 |
| NCT05014646City of Hope Medical CenterLeflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients | 2027-01-16 |
| NCT05136807M.D. Anderson Cancer CenterQuality of Life in Patients With Asymptomatic Monoclonal Gammopathies | 2027-02-02 |
| NCT02886065Massachusetts General HospitalA Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM | 2027-02-15 |
| NCT02960555M.D. Anderson Cancer CenterIsatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR) | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 71 studies in Smoldering Multiple Myeloma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Multiple myeloma (MM), requiring treatment, defined by any of the following:
Exposure to any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.
Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.
Drug: Daratumumab SC: daratumumab + rHuPH20
Drug page: Daratumumab and Hyaluronidase-fihj
Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 \[2000 U/mL\]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.
Also known as: JNJ-54767414
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
Time frame: From randomization (Day -5) up to 77 months
Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses
Time frame: From randomization (Day -5) up to 8 years
Overall Response Rate (ORR)
Time frame: From randomization (Day -5) up to 8 years
Complete Response (CR) Rate
Time frame: From randomization (Day -5) up to 8 years
Time to First-Line Treatment for Multiple Myeloma
Time frame: From randomization (Day -5) up to 8 years
Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2)
Time frame: From randomization (Day -5) up to 8 years
Best Response on First-line Therapy for Multiple Myeloma
Time frame: From randomization (Day -5) up to 8 years
Overall Survival (OS)
Time frame: From randomization (Day -5) up to 8 years
Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features
Time frame: From randomization (Day -5) up to 8 years
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Time frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Time frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Number of Participants With Anti-daratumumab Antibodies
Time frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Time frame: Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Time frame: From Baseline (Day -35) up to 8 years
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Time frame: From Baseline (Day -35) up to 8 years
Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire Score
Time frame: From Baseline (Day -35) up to 8 years
Duration of Response
Time frame: From randomization (Day -5) up to 8 years
Time to Response
Time frame: From randomization (Day -5) up to 8 years
| Milestone | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC |
|---|---|---|
| Started | 196 | 194 |
| Treated | 196 | 193 |
| Completed | 0 | 0 |
| Not completed | 196 | 194 |
| Withdrew: Death | 26 | 15 |
| Withdrew: Withdrawal by subject | 23 | 12 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Randomized in error | 1 | 1 |
| Withdrew: Randomized but not treated | 0 | 1 |
| Withdrew: Ongoing followup | 145 | 163 |
| Withdrew: Principal investigator and participant decision | 0 | 1 |
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
| Months | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | 41.46 (26.41 to 53.32) | NA (66.69 to NA) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Active Monitoring (ACTM) | 26/196 (13.3%) | 38/196 (19.4%) | 140/196 (71.4%) |
| Arm B: Daratumumab SC | 15/194 (7.7%) | 56/193 (29%) | 178/193 (92.2%) |
| Event | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC |
|---|---|---|
| PneumoniaInfections and infestations | 1/196 | 7/193 |
| Covid-19Infections and infestations | 0/196 | 3/193 |
| DiarrhoeaGastrointestinal disorders | 1/196 | 2/193 |
| Inguinal HerniaGastrointestinal disorders | 0/196 | 2/193 |
| Small Intestinal ObstructionGastrointestinal disorders | 1/196 | 2/193 |
| Non-Cardiac Chest PainGeneral disorders | 0/196 | 2/193 |
| CellulitisInfections and infestations | 0/196 | 2/193 |
| Covid-19 PneumoniaInfections and infestations | 1/196 | 2/193 |
| PyelonephritisInfections and infestations | 0/196 | 2/193 |
| SepsisInfections and infestations | 2/196 | 2/193 |
| Event | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC |
|---|---|---|
| FatigueGeneral disorders | 26/196 | 66/193 |
| Upper Respiratory Tract InfectionInfections and infestations | 15/196 | 58/193 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 35/196 | 52/193 |
| DiarrhoeaGastrointestinal disorders | 9/196 | 51/193 |
| NasopharyngitisInfections and infestations | 23/196 | 49/193 |
| Back PainMusculoskeletal and connective tissue disorders | 38/196 | 46/193 |
| InsomniaPsychiatric disorders | 5/196 | 43/193 |
| NauseaGastrointestinal disorders | 9/196 | 37/193 |
| HeadacheNervous system disorders | 13/196 | 35/193 |
| PyrexiaGeneral disorders | 4/196 | 33/193 |
| Age, Continuous(Years) | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC | Total |
|---|---|---|---|
| Mean | 63.0 ± 10.76 | 61.9 ± 11.17 | 62.4 ± 10.97 |
| Sex: Female, Male(Participants) | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC | Total |
|---|---|---|---|
| Female | 103 | 99 | 202 |
| Male | 93 | 95 | 188 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 14 | 23 |
| Not Hispanic or Latino | 176 | 169 | 345 |
| Unknown or Not Reported | 11 | 11 | 22 |
| Race (NIH/OMB)(Participants) | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 3 |
| Asian | 13 | 18 | 31 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 7 | 4 | 11 |
| White | 162 | 161 | 323 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 9 | 10 | 19 |
| Region of Enrollment(Participants) | Arm A: Active Monitoring (ACTM) | Arm B: Daratumumab SC | Total |
|---|---|---|---|
| Belgium | 6 | 4 | 10 |
| France | 9 | 7 | 16 |
| Germany | 4 | 4 | 8 |
| Netherlands | 6 | 3 | 9 |
| United States | 27 | 30 | 57 |
| Argentina | 5 | 4 | 9 |
| Australia | 10 | 5 | 15 |
| Brazil | 3 | 8 | 11 |
| Canada | 6 | 2 | 8 |
| Czech Republic | 2 | 6 | 8 |
| Denmark | 0 | 2 | 2 |
| Greece | 3 | 8 | 11 |
| Hungary | 8 | 4 | 12 |
| Israel | 28 | 28 | 56 |
| Italy | 4 | 8 | 12 |
| Japan | 13 | 15 | 28 |
| Norway | 8 | 7 | 15 |
| Poland | 6 | 6 | 12 |
| Russian Federation | 9 | 4 | 13 |
| Spain | 14 | 10 | 24 |
| Sweden | 3 | 2 | 5 |
| Turkey | 5 | 9 | 14 |
| United Kingdom | 17 | 18 | 35 |
Showing the first 100 of 163 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in May 2024, 77 months.
Results were first posted in Dec 2025, 1 year 7 months after primary completion. A results delay was requested in Apr 2025.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daratumumab and Hyaluronidase-fihj
Janssen Research & Development, LLC →