BLd Combination Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPaul Richardson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed multiple myeloma who haven't had systemic therapy before. They should be relatively active (Karnofsky score ≥60) and not pregnant. Exclusions include serious illnesses, prior cancers (with some exceptions), renal insufficiency, low blood counts, liver enzyme abnormalities, certain heart conditions, uncontrolled diabetes or infections, known drug allergies and HIV.

Inclusion Criteria

I have not received any systemic therapy for my multiple myeloma.

You have to have a negative pregnancy test from a blood or urine sample.

I am 18 years old or older.

+2 more

Exclusion Criteria

You have signs of bleeding from your mouth or inside your body, or your platelets are not working properly.

I do not have any serious infections or health conditions.

Serious medical or psychiatric illness likely to interfere with participation in study

+15 more

Participant Groups

The study tests the safety and effectiveness of a combination therapy using Bortezomib, Lenalidomide, and Dexamethasone in patients with new multiple myeloma. It aims to find the highest safe dose of this mix and how well it works together as an initial treatment.

1Treatment groups

Experimental Treatment

Group I: lenalidomide, dexamethasone, bortezomib combinationExperimental Treatment3 Interventions

In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: