ClinicalTrials.gov record NCT06768489
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or in Combination With Pomalidomide for Multiple Myeloma
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 1b treatment study tests JNJ-79635322 given in combination regimens for people with multiple myeloma, high-risk smoldering multiple myeloma, or immunoglobulin light-chain (AL) amyloidosis. Part 1 (dose escalation) aims to identify recommended Phase 2 dose(s) and schedules; Part 2 (dose expansion) further characterizes safety and tolerability at those doses. Participants receive JNJ-79635322 subcutaneously together with daratumumab, lenalidomide, or pomalidomide depending on the assigned regimen.
What it is studying. The study is testing which doses and schedules of JNJ-79635322 are safe and tolerable when given with daratumumab (with or without lenalidomide) or with pomalidomide. It collects side-effect and laboratory-abnormality data, measures drug concentrations and related pharmacokinetic parameters, and records response outcomes.
What the researchers hope to learn. To identify recommended Phase 2 dose(s) and schedules of JNJ-79635322 in combination regimens; to characterize safety, tolerability, adverse events, clinically significant laboratory abnormalities, pharmacokinetics (drug concentrations and related measures), anti-drug antibodies, and response rates in the studied diseases.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- JNJ-79635322
- Daratumumab
- Pomalidomide
- Lenalidomide
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM):
- Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimens A1 and A3: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimens A2 and A4: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR >=2 prior lines of therapy, including a PI and lenalidomide; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments
- Have a weight >=40 kilograms
- Must have an Eastern Cooperative Oncology Group status of 0 or 2
- Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level >= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level >=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. d) For participants without measurable disease in the serum, urine, or involved FLC: presence of 1 or more focus of extramedullary disease which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at its greatest dimension) diameter on whole body positron emission tomography-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated
- Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis
- Have a histopathological diagnosis of amyloidosis
- Have an ECOG performance status of 0 to 1
- Inclusion criteria for High-risk smoldering multiple myeloma (SMM)
- Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (<=) 5 years with measurable disease at the time of enrollment as defined in the protocol
- Have an ECOG performance status of 0 to 1
Exclusion criteria
- for NDMM and R/R MM:
- Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimens A, C, D and E only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
- Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant <=12 weeks before the first dose of study treatment
- Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
- Prior treatment with CD3-redirecting therapy
- Exclusion Criteria for ND AL Amyloidosis
- Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60 percent (%) plasma cells in the bone marrow, or hypercalcemia
- Macroglossia that impairs swallowing difficulty
- Prior therapy for AL amyloidosis or multiple myeloma
- Exclusion Criteria for High-risk SMM
- Multiple myeloma, requiring treatment
- Primary systemic AL (immunoglobulin light chain) amyloidosis
- Exclusion criteria for all participants:
- Any serious underlying medical conditions, such as: Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment; active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment; cardiovascular dysfunction; pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation; human immunodeficiency (HIV) infection; active hepatitis B or C infection; stroke or seizure within 6 months prior to first dose of study treatment
- Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%)
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive the study drug JNJ-79635322 given subcutaneously together with daratumumab (subcutaneous) and/or oral lenalidomide or pomalidomide, depending on the assigned treatment regimen, in a dose‑finding (Part 1) and dose‑expansion (Part 2) format. During the study participants will have blood (serum) samples taken for drug concentration measurements, testing for anti‑drug antibodies, and laboratory safety monitoring, and investigators will record adverse events and treatment responses over time (outcomes tracked up to about 3 years and 3 months). Dose escalation and de‑escalation decisions will be made by a study evaluation team to establish recommended Phase 2 dose(s) in Part 1; Part 2 treats participants at those selected dose(s). The registry requires that you already have certain diagnostic information to join—for example a histopathological diagnosis for AL amyloidosis and, if used to show measurable disease, prior imaging (whole‑body PET‑CT or whole‑body MRI) or bone marrow plasma‑cell data—and the record does not say the study will perform those diagnostic tests.
How the study is structured. This is a Phase 1, non-randomized treatment study with two parts. Part 1 is dose escalation: participants receive adjusted doses to find recommended Phase 2 dose(s), with dose decisions made by a study evaluation team. Part 2 is dose expansion: participants receive the selected dose(s) to further evaluate safety and tolerability in disease subgroups. The study is open-label (no masking) and assigns participants sequentially into specified combination regimens.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Australia, Israel, Netherlands, Spain, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Dec 4, 2024
- Primary completion
- Jan 2, 2029 (estimated)
- Study completion
- Jun 29, 2029 (estimated)
- Target enrollment
- 276 participants (estimated)
- Last updated on registry
- Sep 25, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Janssen Research & Development, LLC
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Study Contact 📞 844-434-4210 ✉ Participate-In-This-Study1@its.jnj.com
Participating sites (16)
- Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, 80218 · United States
- Winship Cancer Institute Emory UniversityRecruiting
Atlanta, Georgia, 30322 · United States
- Monash Medical CentreRecruiting
Clayton, 3168 · Australia
- St Vincents Hospital MelbourneRecruiting
Fitzroy, 3065 · Australia
- Peter MacCallum Cancer CentreRecruiting
Melbourne, 3000 · Australia
- Calvary Mater Newcastle HospitalRecruiting
Waratah, 2298 · Australia
- Wollongong HospitalRecruiting
Wollongong, 2500 · Australia
- Carmel Medical CenterRecruiting
Haifa, 3436212 · Israel
- Hadassah Medical CenterRecruiting
Jerusalem, 9112001 · Israel
- Sheba Medical CenterRecruiting
Ramat Gan, 52621 · Israel
Terms used on this page · explanations by MedicalUpdates.ai
- primary purpose
- The main reason an interventional study is being done, for example treatment, prevention, diagnosis, supportive care or basic science.
- Dose Escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- Phase 2
- A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
- RP2D
- The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
- relapsed or refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- prior lines
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- free light chain
- Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
- positron emission tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- computed tomography
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- Inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- time frame
- The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
- investigational drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Allogeneic stem cell transplant
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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