Phase
Condition
Cancer/tumors
Platelet Disorders
Leukemia
Treatment
Pomalidomide
Dexamethasone
Daratumumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
Documented evidence of measurable disease:
Serum M-protein level ≥ 1 g/dL
Urine M-protein level ≥ 200 mg/24h
Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serumimmunoglobulin kappa lambda free light chain ratio
Documented evidence of PD by IMWG 2016 criteria based on investigator'sdetermination during or after the most recent line of therapy. Participants withonly 1 prior line of therapy must have progressed within 47 months of a stem celltransplant, or if not transplanted, then within 42 months of starting initialtherapy
Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38antibody. Participant must have undergone at least 2 complete cycles of treatmentfor each line of therapy, unless PD was the best response to the line of therapy
Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) asdetermined by the Investigator.
ECOG performance status score of 0 to 1
Adequate hematology and chemistry laboratory values:
Haemoglobin ≥ 8.0 g/dL
Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3)
Platelet count ≥ 75 × 10^9/L (75000 per mm3) in participants with < 50% of bonemarrow nucleated cells are plasma cells or ≥ 50 × 10^9/L (50000 per mm3) inparticipants with ≥ 50% of bone marrow nucleated cells are plasma cells
Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULNif the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl byCockcroft and Gault method ≥ 30 mL/minute
Exclusion
Exclusion Criteria:
Known active, or prior history of CNS involvement or exhibits clinical signs ofmeningeal involvement of MM.
Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia orPolyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
Participants with primary refractory MM (failed to generate at least a minimalresponse to any prior therapy)
Significant neurological or psychiatric condition
Significant medical condition that places the participant at an unacceptable riskfor treatment-related complications
Previously received any prior BCMA-targeted treatment
Previously received CAR-T or CAR-NK therapy directed at any target
Previously received T-cell engager therapy directed at any target
Previously received allogeneic stem cell transplantation at any time during priortherapy or received autologous stem cell transplantation within 12 weeks ofrandomization
Study Design
Connect with a study center
Research Site
Camperdown, 2050
AustraliaSite Not Available
Research Site
Camperdown 2172563, 2050
AustraliaSite Not Available
Research Site
Darlinghurst, 2010
AustraliaSite Not Available
Research Site
Darlinghurst 2169378, 2010
AustraliaSite Not Available
Research Site
Fitzroy, VIC3065
AustraliaActive - Recruiting
Research Site
Fitzroy 2166584, VIC3065
AustraliaSite Not Available
Research Site
Liverpool, 2170
AustraliaSite Not Available
Research Site
Liverpool 2159851, 2170
AustraliaSite Not Available
Research Site
Melbourne, 3004
AustraliaSite Not Available
Research Site
Melbourne 2158177, 3000
AustraliaSite Not Available
Research Site
Murdoch, WA6150
AustraliaSite Not Available
Research Site
Murdoch 8349091, WA6150
AustraliaSite Not Available
Research Site
Salvador, 41253-190
BrazilSite Not Available
Research Site
Salvador 3450554, 41253-190
BrazilSite Not Available
Research Site
São Paulo, 05652-900
BrazilSite Not Available
Research Site
São Paulo 3448439, 01509-900
BrazilSite Not Available
Research Site
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Research Site
Calgary 5913490, Alberta 5883102 T2N 5G2
CanadaSite Not Available
Research Site
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Research Site
Vancouver 6173331, British Columbia 5909050 V5Z 4E6
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Research Site
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Research Site
Montreal, Quebec H3A 1A1
CanadaSite Not Available
Research Site
Montreal 6077243, Quebec 6115047 H3A 1A1
CanadaSite Not Available
Research Site
Lille, 59037
FranceSite Not Available
Research Site
Lille 2998324, 59037
FranceSite Not Available
Research Site
Nantes, 44093
FranceSite Not Available
Research Site
Nantes 2990969, 44093
FranceSite Not Available
Research Site
Paris, 75010
FranceSite Not Available
Research Site
Paris 2988507, 75010
FranceSite Not Available
Research Site
Pierre-Bénite, 69495
FranceSite Not Available
Research Site
Pierre-Bénite 2987314, 69495
FranceSite Not Available
Research Site
Poitiers, 86021
FranceSite Not Available
Research Site
Poitiers 2986495, 86021
FranceSite Not Available
Research Site
Toulouse, 31059
FranceSite Not Available
Research Site
Toulouse 2972315, 31059
FranceSite Not Available
Research Site
Berlin, 12200
GermanySite Not Available
Research Site
Berlin 2950159, 12200
GermanySite Not Available
Research Site
Dresden, 01307
GermanySite Not Available
Research Site
Dresden 2935022, 01307
GermanySite Not Available
Research Site
Erlangen, 91054
GermanySite Not Available
Research Site
Erlangen 2929567, 91054
GermanySite Not Available
Research Site
Essen, 45147
GermanySite Not Available
Research Site
Essen 2928810, 45147
GermanySite Not Available
Research Site
Freiburg im Breisgau, 79106
GermanySite Not Available
Research Site
Freiburg im Breisgau 2925177, 79106
GermanySite Not Available
Research Site
Hamburg, 20246
GermanySite Not Available
Research Site
Hamburg 2911298, 20246
GermanySite Not Available
Research Site
Leipzig, 04103
GermanySite Not Available
Research Site
Leipzig 2879139, 04103
GermanySite Not Available
Research Site
Mainz, 55131
GermanySite Not Available
Research Site
Mainz 2874225, 55131
GermanySite Not Available
Research Site
Nuremberg, 90419
GermanySite Not Available
Research Site
Nuremberg 2861650, 90419
GermanySite Not Available
Research Site
Würzburg, 97080
GermanySite Not Available
Research Site
Würzburg 2805615, 97080
GermanySite Not Available
Research Site
Bologna, 40138
ItalySite Not Available
Research Site
Bologna 3181928, 40138
ItalySite Not Available
Research Site
Milan, 20132
ItalySite Not Available
Research Site
Milan 6951411, 20132
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Napoli 9031661, 80131
ItalySite Not Available
Research Site
Rozzano, 20089
ItalySite Not Available
Research Site
Rozzano 3168837, 20089
ItalySite Not Available
Research Site
Torino, 10126
ItalySite Not Available
Research Site
Torino 8980539, 10126
ItalySite Not Available
Research Site
Bunkyō City, 113-8431
JapanSite Not Available
Research Site
Bunkyō City 11790632, 113-8431
JapanSite Not Available
Research Site
Kashiwa, 277-8577
JapanSite Not Available
Research Site
Kashiwa 1859924, 277-8577
JapanSite Not Available
Research Site
Kyoto, 602-8566
JapanSite Not Available
Research Site
Kyoto 1857910, 602-8566
JapanSite Not Available
Research Site
Nagoya, 467-8602
JapanSite Not Available
Research Site
Nagoya 1856057, 467-8602
JapanSite Not Available
Research Site
Shibuya-ku, 150-8935
JapanSite Not Available
Research Site
Shinjuku-ku, 160-8582
JapanSite Not Available
Research Site
Oslo, 0450
NorwaySite Not Available
Research Site
Gdansk, 80-952
PolandSite Not Available
Research Site
Gdansk 3099434, 80-952
PolandSite Not Available
Research Site
Gliwice, 44-101
PolandSite Not Available
Research Site
Gliwice 3099230, 44-101
PolandSite Not Available
Research Site
Lublin, 20-090
PolandSite Not Available
Research Site
Lublin 765876, 20-090
PolandSite Not Available
Research Site
Poznan, 60-569
PolandSite Not Available
Research Site
Poznan 3088171, 60-569
PolandSite Not Available
Research Site
Warsaw, 02-776
PolandSite Not Available
Research Site
Warsaw 756135, 02-776
PolandSite Not Available
Research Site
Wroclaw, 50-367
PolandSite Not Available
Research Site
Wroclaw 3081368, 50-367
PolandSite Not Available
Research Site
Seoul, 06351
South KoreaSite Not Available
Research Site
Seoul 1835848, 03080
South KoreaSite Not Available
Research Site
Barcelona, 8035
SpainSite Not Available
Research Site
Barcelona 3128760, 08036
SpainSite Not Available
Research Site
Madrid, 28041
SpainSite Not Available
Research Site
Madrid 3117735, 28041
SpainSite Not Available
Research Site
Pamplona, 31008
SpainSite Not Available
Research Site
Pamplona 3114472, 31008
SpainSite Not Available
Research Site
Salamanca, 37007
SpainSite Not Available
Research Site
Salamanca 3111108, 37007
SpainSite Not Available
Research Site
Santander, 39008
SpainSite Not Available
Research Site
Santander 3109718, 39008
SpainSite Not Available
Research Site
Valencia, 46026
SpainSite Not Available
Research Site
Valencia 2509954, 46026
SpainSite Not Available
Research Site
Taipei, 106
TaiwanSite Not Available
Research Site
Taipei 1668341, 112
TaiwanSite Not Available
Research Site
Birmingham, B9 5SS
United KingdomSite Not Available
Research Site
Birmingham 2655603, B9 5SS
United KingdomSite Not Available
Research Site
Bristol, BS2 8ED
United KingdomSite Not Available
Research Site
Bristol 2654675, BS2 8ED
United KingdomSite Not Available
Research Site
Glasgow, Scotland, G12 0YN
United KingdomSite Not Available
Research Site
London, SM2 5NG
United KingdomSite Not Available
Research Site
London 2643743, SM2 5NG
United KingdomSite Not Available
Research Site
Gilbert, Arizona 85234
United StatesSite Not Available
Research Site
Phoenix, Arizona 85054
United StatesSite Not Available
Research Site
Tucson, Arizona 85719
United StatesSite Not Available
Research Site
Gilbert 5295903, Arizona 5551752 85234
United StatesSite Not Available
Research Site
Phoenix 5308655, Arizona 5551752 85054
United StatesSite Not Available
Research Site
Tucson 5318313, Arizona 5551752 85719
United StatesSite Not Available
Research Site
La Jolla, California 92093
United StatesSite Not Available
Research Site
Santa Monica, California 90404
United StatesSite Not Available
Research Site
La Jolla 5363943, California 5332921 92093
United StatesSite Not Available
Research Site
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
Research Site
Denver, Colorado 80218
United StatesSite Not Available
Research Site
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Research Site
New Haven, Connecticut 06510
United StatesSite Not Available
Research Site
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Research Site
Washington D.C., District of Columbia 20007
United StatesSite Not Available
Research Site
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Research Site
Chicago, Illinois 60612
United StatesSite Not Available
Research Site
Park Ridge, Illinois 60068
United StatesSite Not Available
Research Site
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Research Site
Park Ridge 4905367, Illinois 4896861 60068
United StatesSite Not Available
Research Site
Iowa City, Iowa 52242
United StatesSite Not Available
Research Site
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Research Site
Louisville, Kentucky 40207
United StatesSite Not Available
Research Site
Louisville 4299276, Kentucky 6254925 40207
United StatesSite Not Available
Research Site
Boston, Massachusetts 02215
United StatesSite Not Available
Research Site
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Research Site
Detroit, Michigan 48202
United StatesSite Not Available
Research Site
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Research Site
New York, New York 10016
United StatesSite Not Available
Research Site
The Bronx, New York 10467
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Research Site
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Research Site
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Research Site
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28204
United StatesSite Not Available
Research Site
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Research Site
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
Research Site
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Research Site
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45220
United StatesSite Not Available
Research Site
Cleveland, Ohio 44195
United StatesSite Not Available
Research Site
Cincinnati 4508722, Ohio 5165418 45220
United StatesSite Not Available
Research Site
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Research Site
Charleston, South Carolina 29425
United StatesSite Not Available
Research Site
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Research Site
Nashville, Tennessee 37203
United StatesSite Not Available
Research Site
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Research Site
Austin, Texas 78704
United StatesSite Not Available
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Austin 4671654, Texas 4736286 78704
United StatesSite Not Available
Research Site
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Research Site
Salt Lake City, Utah 84112
United StatesSite Not Available
Research Site
Salt Lake City 5780993, Utah 5549030 84112
United StatesSite Not Available
Research Site
Charlottesville, Virginia 22908
United StatesSite Not Available
Research Site
Richmond, Virginia 23298
United StatesSite Not Available
Research Site
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
Research Site
Richmond 4781708, Virginia 6254928 23298
United StatesSite Not Available
Research Site
Seattle, Washington 98104
United StatesSite Not Available
Research Site
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
Research Site
Madison, Wisconsin 53792
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Research Site
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available
Research Site
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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