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Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)

NCT01531998 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-06-19

Study results available
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Summary

The goal of this clinical research study is to find the highest tolerable dose of Siltuximab that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone to patients with MM. The safety of this drug combination will also be studied.

Conditions

Interventions

DRUG

Lenalidomide

Induction Phase: 25 mg by mouth daily on Days 1-14. Maintenance Phase: at last tolerated dose from Induction Phase day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg.

DRUG

Bortezomib

Induction Phase: 1.3 mg/m2 by vein daily on Days 1, 4, 8 and 11. Maintenance Phase: 1.3 mg/m2 by vein or last tolerated dose on Day 1 and Day 8.

DRUG

Siltuximab

Induction Phase Starting Dose: 11 mg/kg by vein on Day 1. Maintenance Phase: 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy.

DRUG

Dexamethasone

Induction Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. Maintenance Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. If participant still on Dexamethasone, when entering Maintenance Phase, dose reduced to 20 mg a week.

BEHAVIORAL

Questionnaires

M. D. Anderson Symptom Inventory Module (MDASI-MM) completed Day 1, Day 8 of Cycle 1 - 8, and on Day 1 of Cycle 9 and beyond.

Sponsors & Collaborators

  • Janssen Services, LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jatin J. Shah, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531998 on ClinicalTrials.gov