Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)

NCT ID: NCT01782963

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-12-31

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.

Detailed Description

If you are willing to participate in this study you will be asked to undergo some screening procedures and tests to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care. They may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical exam, performance status, vital signs, neurological exam, bone imaging studies, chest x-ray, bone marrow aspirate, ECG, blood tests and urine tests. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.

For cycles 1-9 (each cycle lasts 35 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib- once a day on Days 1, 8, 15 and 22. If you are one of the first ten patients enrolled you will get Bortezomib as an intravenous injection for the first cycle. You will get Bortezomib as an injection under the skin for all other cycles. If you are not one of the first 10 patients enrolled you will get Bortezomib as an injection under the skin for all cycles. Dexamethasone-if you are 75 years old or younger you will get Dexamethasone on Days 1, 2, 8, 9, 15, 16, 22 and 23. If you are more than 75 years old you will get Dexamethasone on Days 1, 8, 15 and 22. You will take Dexamethasone by mouth at the same time each day.

For cycles 10-15 (each cycle lasts 28 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib-Once a day on Days 1 and 15. You will get Bortezomib as an injection under the skin. You will be given a drug diary to record taking your doses of the drugs. The study staff will tell you how to complete the diary.

During the study you will have to come to the clinic for visits. The tests and procedures that will be done at each visit are listed below:

Day 1 of all cycles: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum (cycle 1 only), urine test.

Day 8 of cycles 1-9: questions about health, medications etc., vital signs, blood tests.

Day 15 of all cycles: questions about health, medications, etc., vital signs, blood tests, pregnancy test.

Day 22 of cycles 1-9: questions about health, medications, etc., vital signs, blood tests.

After the final dose of the study drug you will have an End of Treatment visit. The following tests and procedures will be done at this visit: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum, urine test.

After your End of Treatment visit, we would like to follow your status every 2 months until your disease gets worse. The following tests and procedures will be done at these follow-up visits: questions about health, medications, symptoms etc., blood tests and urine test.

If you are one of the first twenty patients enrolled in the study you will also be asked to provide additional blood samples to study what the body does to the study drug. We will take one sample at five time points during cycle 1 and 2. Collection of these samples may require you to come back into the clinic on additional days when you are not receiving study drugs.

You will be in this research study for about 15 months. You can be in this study for a maximum of 15 cycles. If your disease gets worse before the 15th cycle you will be taken off the study.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)

Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

Bortezomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

Lenalidomide

Intervention Type: DRUG

Bortezomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Other Intervention Names

Revlimid; Velcade

Eligibility Criteria

Inclusion Criteria

• Documented symptomatic myeloma, with organ damage related to myeloma
• Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
• Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method

Exclusion Criteria

• Eligible for autologous stem cell transplantation
• HIV positive on combination antiretroviral therapy
• Pregnant or breastfeeding
• Treated with any prior systemic therapy
• Primary amyloidosis or myeloma complicated by amyloidosis
• Receiving other investigational agents within 14 days of the start of this trial or during this trial
• Known brain metastases
• Poor tolerability or known allergy to any of the study drugs or similar compounds
• Intercurrent illness
• Previous history of another malignant condition except for basal cell carcinoma or stage I cervical cancer
• Inability to comply with an anti-thrombotic treatment regimen
• Peripheral neuropathy greater than or equal to grade 2

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Noopur Raje

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

John Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital/North Shore Cancer Center

Danvers, Massachusetts, United States

Countries

United States

Other Identifiers

12-498

Identifier Type: -

Identifier Source: org_study_id