Brief Title
Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
Official Title
Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia
Brief Summary
This phase I trial studies the side effects and best dose of pomalidomide in treating
patients with Waldenstrom macroglobulinemia that has returned after a period of improvement
(relapsed) or does not respond to treatment (refractory). Pomalidomide may stimulate the
immune system in different ways and stop cancer cells from growing.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of pomalidomide in patients with relapsed or
refractory Waldenstrom macroglobulinemia.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity profile of pomalidomide in patients with relapsed or
refractory Waldenstrom macroglobulinemia.
II. To evaluate the efficacy of pomalidomide in patients with relapsed or refractory
Waldenstrom macroglobulinemia.
OUTLINE: This is a dose-escalation study.
Patients receive pomalidomide orally (PO) on days 1-28 or 1-21. Courses repeat every 21 or 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum tolerated dose (MTD) of pomalidomide
Condition
Recurrent Waldenstrom Macroglobulinemia
Intervention
Pomalidomide
Study Arms / Comparison Groups
Treatment (pomalidomide)
Description: Patients receive pomalidomide PO on days 1-28 or 1-21. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
October 6, 2010
Completion Date
October 31, 2023
Primary Completion Date
October 31, 2023
Eligibility Criteria
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Waldenstrom's macroglobulinemia that has relapsed and/or is refractory to at least one
prior line of therapy
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry
- Serum creatinine =< 2.0 mg/dL
- Creatinine clearance >= 45 ml/min
- Total bilirubin =< 3 x upper limit of normal (ULN) or direct bilirubin =< 2 x ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x
ULN
- Platelet count >= 20 K/microL
- Absolute neutrophil count >= 500 K/microL
- Disease free of prior malignancies for >= 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or
breast
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 25 mIU/mL within 10 to 14 days prior to and again
within 24 hours of starting pomalidomide 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 pomalidomide; FCBP must also agree to
ongoing pregnancy testing; men must agree to practice complete abstinence or agree use
a latex condom during sexual contact with a FCBP while participating in the study,
during dose interruptions and for at least 90 days following study drug
discontinuation, 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
- Able to take aspirin (325 mg) daily as prophylactic anticoagulation (patients
intolerant to acetylsalicylic acid [ASA] may use therapeutic dose warfarin or low
molecular weight heparin)
- All study participants must be registered into the mandatory POMALYST REMS program,
and be willing and able to comply with the requirements of the POMALYST REMS program
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, 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 pomalidomide or for 28 days after stopping pomalidomide)
- Any medical or psychiatric condition, including the presence of laboratory
abnormalities, which places the subject at unacceptable risk if he/she were to
participate in the study, or confounds the ability to interpret data from the study
- Use of any other experimental drug or therapy within 28 days of the first dose of
study drug
- Known hypersensitivity to thalidomide or lenalidomide
- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs
- Any prior use of pomalidomide
- Concurrent use of other anti-cancer agents or treatments
- Known positive for human immunodeficiency virus (HIV) or acute hepatitis A or acute or
chronic active hepatitis B or C
- Grade > 2 peripheral neuropathy
- Neutrophil count < 1000 K/microL and/or
- Platelet count < 100 K/microL unless infiltration by Waldenström's macroglobulinemia
equals or exceed 60% of bone marrow cellularity
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sheeba K Thomas, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01198067
Organization ID
2009-0972
Secondary IDs
NCI-2012-01882
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Sheeba K Thomas, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
October 2022