Overview

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma

Status:
Completed
Trial end date:
2018-07-20
Target enrollment:
0
Participant gender:
All
Summary
This phase I/II trial studies the best dose and side effects of lenalidomide and thalidomide, and how well they work with dexamethasone in treating participants with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, thalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Celgene
National Cancer Institute (NCI)
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ichthammol
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Relapsed/refractory multiple myeloma (MM) with measurable levels of myeloma
paraprotein in serum (>= 0.5 g/dl), urine (>= 0.2 g excreted in a 24-hour collection
sample), or abnormal free light chain (FLC) ratio

- Serum creatinine =< 2.5 mg/dl

- Females of childbearing potential (FCBP)* must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and
again within 24 hours of starting lenalidomide and must either commit to continued
abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
control, one highly effective method and one additional effective method AT THE SAME
TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to
ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact
with a female of childbearing potential even if they have had a successful vasectomy.
All patients must be counseled at a minimum of every 28 days about pregnancy
precautions and risks of fetal exposure.

- A female of childbearing potential is a sexually mature woman who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 24 consecutive months (i.e., has had menses at any
time in the preceding 24 consecutive months).

- Absolute neutrophil count > 1000 cells/mm^3

- Platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells
and platelet count > 25,000 cells/mm^3 for patients in whom > 50% of the bone marrow
nucleated cells were plasma cells

- Total bilirubin =< 2.0 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 x
upper limit of normal (ULN)

- Able to take prophylactic anticoagulation, warfarin or equivalent agent

- Patient is able to understand and comply with the terms and conditions of the
lenalidomide and thalidomide counseling program

- All study participants must be registered into the mandatory RevAssist program, and be
willing and able to comply with the requirements of RevAssist, AND the S.T.E.P.S.
program

Exclusion Criteria:

- Any serious medical condition, or psychiatric illness that would prevent the subject
from signing the informed consent form

- Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide)

- Use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy
(radiation therapy allowed within 5 days of completion of radiation therapy).

- Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.