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NCT04052880 : Phase 2 - SubQ Dara + Dose-Atten. Bortezomib, Lenalidomide, Dex New MM >70 years

Updated: May 24

Official Title: A Phase 2 Study of Subcutaneous Daratumumab in Combination With Dose-Attenuated Bortezomib, Lenalidomide, and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients

Subcutaneous Daratumumab in Combination With Dose-Attenuated Bortezomib, Lenalidomide, and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients

This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. Subjects will receive subcutaneous daratumumab, dose-attenuated bortezomib, revlimid, and dexamethasone until confirmed disease progression, discontinuation of study treatment due to unacceptable drug toxicity, or other reasons. Throughout the study, subjects will be monitored closely for adverse events, laboratory abnormalities, and clinical response.


Sponsor

Ajai Chari


Collaborator

Janssen, LP

 

ClinicalTrials.gov Identifier: NCT04052880


Official Title: A Phase 2 Study of Subcutaneous Daratumumab in Combination With Dose-Attenuated Bortezomib, Lenalidomide, and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients


First Posted: August 12, 2019


Click here for details on ClinicalTrials.gov

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

* Bortezomib (Velcade)

* Lenalidomide (Revlimid)

* Dexamethasone (Decadron)

* Daratumumab (Darzalex)

 

Location

United States, New York

New York: Tisch Cancer Institute Mount Sinai Hospital New York

 

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