Actively Recruiting
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
180
Participants Needed
29
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
CONDITIONS
Official Title
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
For participants with relapsed or refractory multiple myeloma:
- Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
- Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (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 (EMD) 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 and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)
For participants with previously treated AL amyloidosis:
- Initial histopathological diagnosis of amyloidosis
- Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
- Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
- One or more organs impacted by systemic AL amyloidosis
- Left ventricular ejection fraction (LVEF) >=45%
You will not qualify if you...
For participants with relapsed or refractory multiple myeloma:
- Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
- The following medical conditions: 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, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
- Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration
For participants with previously treated AL amyloidosis:
- CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
- Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- Pulmonary compromise requiring supplemental oxygen use
- Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
- Previous or current diagnosis of symptomatic multiple myeloma
- Macroglossia that impairs swallowing difficulty
- Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
AI-Screening
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Trial Site Locations
Total: 29 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
5
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Levine Cancer Institute
Charlotte, North Carolina, United States, 28001
Actively Recruiting
8
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
11
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
12
CHU de Liege
Liège, Belgium, 4000
Actively Recruiting
13
CHU Nantes
Nantes, France, 44093
Actively Recruiting
14
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
15
Chu Rennes Hopital Pontchaillou
Rennes, France, 35000
Completed
16
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
17
Japanese Red Cross Medical Center
Shibuya City, Japan, 150-8935
Actively Recruiting
18
Osaka University Hospital
Suita-shi, Japan, 565-0871
Actively Recruiting
19
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Completed
20
VUMC Amsterdam
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
21
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
22
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
23
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
24
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
25
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
26
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
27
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
28
University College Hospital
London, United Kingdom, W1T 7HA
Actively Recruiting
29
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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