MDACC Study Summary 2009-0972

Study Summary
No. 2009-0972:.......Lymphoma; Myeloma......Sheeba K. Thomas......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2009-0972

Study Title:	Phase I Study of Pomalidomide in relapsed or refractory Waldenstrom Macroglobulinemia

Physician

New Patient Referral



Name:	Sheeba K. Thomas	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma Myeloma	Supported By:	Celgene Corporation

Phase of Study:	Phase I	Return Visit:	Return to clinic visits will occur once a week during the first cycle and monthly thereafter.

Treatment Agents:	Pomalidomide	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	no hospitalization


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given to patients with relapsed or refractory WM. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary objectives

· To determine the maximum tolerated dose (MTD) of pomalidomide in patients with relapsed or refractory Waldenstrom Macroglobulinemia

Secondary study objectives

· To evaluate the safety and toxicity profile of pomalidomide in patients with relapsed or refractory Waldenstrom Macroglobulinemia
· To evaluate the efficacy of pomalidomide in patients with relapsed or refractory Waldenstrom Macroglobulinemia

Study Status Information



Study Activation / Registration Date:	10/06/2010

IRB Review and Approval Date:	10/06/2010

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Understand and voluntarily sign an informed consent form

2) Age >/= 18 years at the time of signing the informed consent form

3) Able to adhere to the study visit schedule and other protocol requirements

4) Waldenström's Macroglobulinemia that has relapsed and/or is refractory to at least one prior line of therapy

5) All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study

6) ECOG performance status of </= 2 at study entry

7) Laboratory test results within these ranges: 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; AST (SGOT) and ALT (SGPT) </= 2 x ULN; Platelet count >/= 20 K/microL; Absolute neutrophil count >/= 500 K/microL

8) 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

9) 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

10) Continued from Inclusion #9: 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

11) Able to take aspirin (325mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use therapeutic dose warfarin or low molecular weight heparin).

Exclusion Criteria:

1) Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

2) Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide or for 28 days after stopping pomalidomide)

3) 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

4) Use of any other experimental drug or therapy within 28 days of the first dose of study drug

5) Known hypersensitivity to thalidomide or lenalidomide

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

7) Any prior use of pomalidomide

8) Concurrent use of other anti-cancer agents or treatments

9) Known positive for HIV or acute hepatitis A or acute or chronic active hepatitis B or C

10) Grade >2 peripheral neuropathy

11) Neutrophil count <1000K/microL and/or platelet count <100K/microL unless infiltration by Waldenström's Macroglobulinemia equals or exceed 60% of bone marrow cellularity.

Links

Registration Number: NCT01198067
Study Information on Clinical Trials Registry (clinicaltrials.gov)