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A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma


Phase 2
60 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

To evaluate the objective response rate (PR [Partial Response] + VGPR [Very Good Partial Response] + CR [Complete Response]) of modified RVD (weekly subcutaneous bortezomib [Velcade], lenalidomide [Revlimid], and dexamethasone) in previously untreated multiple myeloma patients who are ineligible for high dose therapy with autologous stem cell transplant.

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

12-498

NCT ID:

NCT01782963

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Newly diagnosed
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Massachusetts General Hospital/North Shore Cancer CenterDanvers, Massachusetts  01923