Phase
Condition
Multiple Myeloma
Platelet Disorders
Cancer
Treatment
JNJ-79635322
Daratumumab
Pomalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have documented initial diagnosis of multiple myeloma according to IMWG diagnosticcriteria
Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimen A1: Have been treated with 1 to 3 priorlines of therapy, including a proteasome inhibitor (PI) and an inhibitor,immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM);Treatment regimen A2: Newly diagnosed MM naïve to multiple myeloma (or other relatedplasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 priorline of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR >=2 prior lines of therapy, including a PI and lenalidomide
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 multiplemyeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormalserum Ig kappa lambda FLC ratio. d) For participants without measurable disease inthe serum, urine, or involved FLC: presence of 1 or more focus of extramedullarydisease which meets the following criteria: extramedullary plasmacytoma notcontiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at itsgreatest dimension) diameter on whole body positron emission tomography-computedtomography (or whole-body magnetic resonance imaging approved by sponsor), and notpreviously radiated
Exclusion
Exclusion Criteria:
Any serious underlying medical conditions, such as: a) Evidence of active viral,bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial,or antifungal treatment. b) Active autoimmune disease requiring systemicimmunosuppressive therapy within 6 months before start of study treatment. c)Cardiac conditions (myocardial infarction, unstable angina, or coronary arterybypass graft <=6 months prior to enrollment; New york heart association stage III orIV congestive heart failure etcetera)
Prior antitumor therapy as follows, in the specified time frame prior to the firstdose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonalantibody (mAb) treatment, or treatment with an investigational drug or an invasiveinvestigational 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 directedtherapy within 90 days (for treatment regimen A only; within 21 days for treatmentregimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14days
Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months beforethe first dose of study treatment. b) Received an autologous stem cell transplantless than or equal to (<=)12 weeks before the first dose of study treatment
Nonhematologic toxicity from prior anticancer therapy that has not resolved tobaseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade]or peripheral neuropathy grade <=3)
Prior treatment with CD3-redirecting therapy
The following medical conditions: pulmonary compromise requiring supplemental oxygenuse to maintain adequate oxygenation, human immunodeficiency (HIV) infection, activehepatitis B or C infection, stroke or seizure within 6 months prior to first dose ofstudy treatment
Study Design
Connect with a study center
Monash Medical Centre
Clayton, 3168
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaActive - Recruiting
Calvary Mater Newcastle Hospital
Waratah, 2298
AustraliaActive - Recruiting
Carmel Medical Center
Haifa, 3436212
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv Yafo, 64239
IsraelActive - Recruiting
VU Medisch Centrum
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainActive - Recruiting
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