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Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3) Trials 2003-33 and 2006-66


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3) Trials 2003-33 and 2006-66


Determine the associated toxicities in qualitative and quantitative terms using NCI
CTCAE(NCI common terminology for adverse events)


Inclusion Criteria:



- Male and female participants of all races/ethnicities with multiple myeloma
previously enrolled on UARK 2003-33 or 2006-66.

- Participant has completed 3 years of maintenance therapy with one of the three study
drugs of VTD or VRD and disease status has remained event free (includes patients who
prematurely discontinued maintenance therapy as long as 3 years have elapsed since
beginning of maintenance).

- All patients must be ages 18 years of age or greater at the time of signing the
informed consent form.

- Participant has adequate hematopoietic reserve, defined as platelets > 50,000/μL (in
participants with bone marrow hypoplasia, remaining peripheral blood progenitor cells
can be infused to boost hematopoietic reserve prior to enrollment).

- Participant has adequate renal function defined as serum creatinine < 3 mg/dL prior
to enrolling on study

- Total bilirubin ≤ 1.5 mg/dL prior to enrolling on study

- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN prior to enrolling on study

- Patient must have signed an IRB-approved informed consent and understand the
investigational nature of the study.

- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®

- Pregnant or nursing women may not participate. Females of childbearing potential
(FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at
least 50 mIU/mL within 10 - 14 days prior to and again within

- 24 hours of prescribing Revlimid® (lenalidomide; prescriptions must be filled within
7 days) 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 Revlimid® (lenalidomide).

- FCBP must also agree to ongoing pregnancy testing.

- Lactating females must agree that they will not breastfeed.

- Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy. See Appendix: Risks of Fetal Exposure,

- Pregnancy Testing Guidelines and Acceptable Birth Control Methods † A female of
childbearing potential is a sexually mature woman who:

- has not undergone a hysterectomy or bilateral oophorectomy

- 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).

Exclusion Criteria:

- Any condition that the PI believes, laboratory abnormality, or psychiatric illness
that would prevent the subject from being enrolled in the research study.

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

- Any 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 baseline.

- Known hypersensitivity to thalidomide.

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

- Concurrent use of other anti-cancer agents or treatments.

- Known positive for HIV or infectious hepatitis, type B or C.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Duration of complete or near complete response w/ Revlimid therapy compared to group with no Revlimid therapy

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS Myeloma Institute for Research & Therapy

Authority:

United States: Institutional Review Board

Study ID:

UARK 2009-09

NCT ID:

NCT01621672

Start Date:

April 2010

Completion Date:

April 2014

Related Keywords:

  • Multiple Myeloma
  • Revlimid
  • progression free
  • Lenalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Science-MIRTLittle Rock, Arkansas  72205