A Phase 1 interventional study of JNJ-79635322 and Daratumumab in Multiple Myeloma, Smoldering Multiple Myeloma and Immunoglobulin Light-chain Amyloidosis, sponsored by Janssen Research & Development, LLC. Recruiting at 16 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
Among 126 studies in Multiple Myeloma by Johnson & Johnson — 13 open to participants now, 33 under way, 12 of them phase 3. Multiple Myeloma · Johnson & Johnson.
Among the 126 studies in Multiple Myeloma by Johnson & Johnson, this one is the 24th largest by planned enrollment of the 100 interventional ones that give a count, is one of 7 that started in 2024, is one of 24 in phase 1, reaches primary completion later than 23 of the 32 other live ones, and was the 118th registered.
3,763 studies on the registry are indexed under Multiple Myeloma; 772 are open to participants now.
Browse Multiple Myeloma studies →13 of the 126 studies in Multiple Myeloma by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in Australia, Czechia, France and 11 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Argentina, Australia and 7 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Australia, Brazil and 15 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Australia, Brazil and 12 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Australia, Spain
Ages 18–80
By country, each count listing its studies:
Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 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.
126 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 28 · Phase 2 37 · Phase 3 36 · Phase 4 4
First in 1995; this study’s year is marked. 7 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 276 is above the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.
Median enrollment 125 across the 100 interventional studies, 255 across the 18 observational. Of the 82 that completed or were terminated, 33 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
9 of the studies in Multiple Myeloma by Johnson & Johnson that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05455320Phase 3Janssen Research & Development, LLCA Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment | 2027-07-30 |
| NCT07030517Johnson & Johnson Private LimitedA Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma | 2027-02-12 |
| NCT04133636Janssen Research & Development, LLCA Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma | 2027-02-26 |
| NCT04108195Janssen Research & Development, LLCA Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma | 2027-04-07 |
| NCT05652335Janssen Research & Development, LLCA Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis | 2027-04-19 |
Add all 9 to your calendar (.ics) → With an account.
Among the 126 studies in Multiple Myeloma by Johnson & Johnson, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and multiple myeloma (R/R MM):
Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis
Inclusion criteria for High-risk smoldering multiple myeloma (SMM)
Exclusion Criteria for NDMM and R/R MM:
Exclusion Criteria for ND AL Amyloidosis
Exclusion Criteria for High-risk SMM
Exclusion criteria for all participants:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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 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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D\[s\]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Drug: JNJ-79635322 · Drug: Daratumumab
Participants who 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 will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Drug: JNJ-79635322 · Drug: Pomalidomide
Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Drug: JNJ-79635322 · Drug: Daratumumab · Drug: Lenalidomide
Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Drug: JNJ-79635322 · Drug: Daratumumab
Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Drug: JNJ-79635322 · Drug: Daratumumab
JNJ-79635322 will be administered subcutaneously.
Daratumumab will be administered subcutaneously.
Pomalidomide will be administered orally.
Lenalidomide will be administered orally.
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 28 days
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 3 Years and 3 months
Number of Participants with Clinically Significant Laboratory Abnormalities
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Time frame: Up to 3 Years and 3 months
Percentage of Participants With Overall Response Rate
Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Time frame: Up to 3 Years and 3 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response \[sCR\]+ complete response \[CR\]+VGPR) according to the IMWG 2016 criteria.
Time frame: Up to 3 Years and 3 months
Percentage of Participants With CR or Better Response Rate
CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Time frame: Up to 3 Years and 3 months
Percentage of Participants With sCR or Better Response Rate
sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria.
Time frame: Up to 3 Years and 3 months
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM.
Time frame: Up to 3 Years and 3 months
Time to Response (TTR)
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Time frame: Up to 3 Years and 3 months
Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported.
Time frame: Up to 3 Years and 3 months
DOR as Defined by International Amyloidosis Consensus Criteria
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis.
Time frame: Up to 3 Years and 3 months
TTR as Defined by International Amyloidosis Consensus Criteria
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria.
Time frame: Up to 3 Years and 3 months
Serum Concentration of JNJ-79635322 and Daratumumab
Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Time frame: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
AUCinf for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
AUCtau for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Cmax for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Half Life (T1/2) for JNJ-79635322 and Daratumumab
T1/2 for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Tmax for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
CL/F for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Vss/F for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
Started Dec 2024 (actual). Primary completion is estimated for Jan 2029, 48 months after the start.
Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 48 months is above that.
Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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