Phase
Condition
Multiple Myeloma
Platelet Disorders
Red Blood Cell Disorders
Treatment
Lenalidomide
JNJ-79635322
Daratumumab
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; Treatment Regimens C,D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cellneoplasm)-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 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 et cetera)
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
Monash Medical Centre
Clayton 2171400, 3168
AustraliaSite Not Available
St Vincents Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy 2166584, 3065
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne 2158177, 3000
AustraliaSite Not Available
Calvary Mater Newcastle Hospital
Waratah, 2298
AustraliaActive - Recruiting
Calvary Mater Newcastle Hospital
Waratah 10103871, 2298
AustraliaSite Not Available
Wollongong Hospital
Wollongong, 2500
AustraliaActive - Recruiting
Wollongong Hospital
Wollongong 2171507, 2500
AustraliaSite Not Available
Carmel Medical Center
Haifa, 3436212
IsraelActive - Recruiting
Carmel Medical Center
Haifa 294801, 3436212
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem 281184, 9112001
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan 293788, 52621
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv 293397, 64239
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv Yafo, 64239
IsraelSite Not Available
VU Medisch Centrum
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
VU Medisch Centrum
Amsterdam 2759794, 1081 HV
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Universitair Medisch Centrum Groningen
Groningen 2755251, 9713 GZ
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht 2745912, 3584 CX
NetherlandsSite Not Available
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona 3128760, 08036
SpainSite Not Available
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hosp Clinico Univ de Salamanca
Salamanca 3111108, 37007
SpainSite Not Available

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