Clinical trial NCT05514990: Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
Official title: A Phase 1b/2 Study of Standard Doses of Bortezomib and Pembrolizumab ± Reovirus (Pelareorep) Combination Therapy in Patients With Relapsed Multiple Myeloma (AMBUSH Study)
Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Summary: This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. A virus modified in the laboratory, such as pelareorep, may be able to kill cancer cells without damaging normal cells. Giving the combination of bortezomib, dexamethasone, and pembrolizumab with pelareorep may work better in treating patient with multiple myeloma.
Interventions:
description: Given SC or IV
name: Bortezomib
other_name: LDP 341
MLN341
PS-341
PS341
Velcade
[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
type: Drug
description: Given PO, IV, or IM
name: Dexamethasone
other_name: Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron
Decadron DP
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasone Intensol
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Dxevo
Fluorodelta
Fortecortin
Gammacorten
Hemady
Hexadecadrol
Hexadrol
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
TaperDex
Visumetazone
ZoDex
type: Drug
description: Given IV
name: Pelareorep
other_name: PO BB0209
PO-BB0209
Reolysin
Reovirus Serotype 3
Wild-type Reovirus
type: Biological
description: Given IV
name: Pembrolizumab
other_name: Keytruda
Lambrolizumab
MK-3475
SCH 900475
type: Biological
Study arms:
design_group_description: Patients receive bortezomib SC) or IV and dexamethasone PO, IV, or IM on days 1, 8, and 15 of each cycle. Patients also receive pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Cohort I (standard therapy)
design_group_type: Experimental
design_group_description: Patients receive bortezomib SC or IV and dexamethasone either PO, IV, or IM on days 1, 8, and 15 of each cycle. Patients also receive pelareorep IV over 60 minutes on days 1, 2, 8, 9, 15, and 16 and pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Cohort II (standard therapy, pelareorep)
design_group_type: Experimental
Sponsor: University of Southern California
Collaborators: National Cancer Institute
Drug name mappings:
name: Pelareorep
lang: EN
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 硼替佐米
lang: CN
name: Bortezomib
lang: EN
name: ボルテゾミブ
lang: JP