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Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone Vs Lenalidomide, Bortezomib, and Dexamethasone in Subjects W/ Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy & Autologous SCT

Clinical Trial Details

This study is for men and women with newly diagnosed multiple myeloma, between the ages of 18 and 70, who have never been treated for their multiple myeloma. The study is being done primarily to look at whether or not adding daratumumab to standard of care treatment — Revlimid, Velcade, and dexamethasone (RVd) — will help patients with newly diagnosed Multiple Myeloma achieve a better response after receiving treatment with RVd, with or without daratumumab, and an autologous stem cell transplant (ASCT). The study will examine whether adding daratumumab to RVd treatment affects the effectiveness of treatment, compared to RVd alone. Daratumumab is a monoclonal human antibody. An antibody is something that finds and kills foreign objects in your body, in this case myeloma cells. This antibody, daratumumab, recognizes a specific protein, CD38, which is often found on multiple myeloma cells. Datarumumab has been approved by the FDA for treatment of multiple myeloma patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. It is currently sold as DARZALEX. Initially, there will be a safety run-in phase in up-to-16 subjects to assess the safety of adding daratumumab to the RVd regimen (standard of care). The main study consists of 4 phases: a 28-day screening phase; an induction/consolidation phase (which includes four 21-day induction treatment cycles followed by stem cell mobilization, high dose therapy, and stem cell transplant, followed by two 21-day consolidation treatment cycles); a 24-month maintenance phase that starts after the post-ASCT consolidation disease evaluation; and a long-term follow-up phase. All patients will be followed in the long-term follow-up phase for at least 1 year after last dose of study treatment and will continue until they pass away or the study ends. After the safety run-in phase, about 200 patients will be randomly assigned to 1 of 2 treatment groups for the main study. 

Group 1: This group will receive daratumumab plus the standard of care treatment, which includes lenalidomide, bortezomib and dexamethasone. We call this treatment group the D-RVd group. 

Group 2: This group will receive the standard of care treatment, which includes lenalidomide, bortezomib and dexamethasone. We call this group the RVd group, because this group will not receive daratumumab. Patients will receive lanaldomide and velcade 

Subjects will receive study treatment through completion of the 24-month maintenance phase, or until confirmed disease progression, discontinue study treatment due to an unacceptable drug toxicity, or other reasons. 

Key Eligibility: 

- Men and women ages 18 - 70 
- A confirmed diagnosis of symptomatic multiple myeloma and measureable secretory disease 
- ECOG performance score of 0 or 1 
- Has not received system therapy for multiple myeloma (with the exception being dexamethasone) 
- Detailed eligibility reviewed when you contact the study team 

Contact

Linda Tegnestam
lit2011@med.cornell.edu
646 962 6500

Primary Investigator

Ruben Niesvizky M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1611017759

ClinicalTrials.gov:

NCT02874742

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

2