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Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy

Pomalidomide is a 2nd generation immunomodulatory agent (IMiD®) with greater efficacy than
lenalidomide and with a similar toxicity spectrum. Phase I trials have shown that
pomalidomide 1 to 5 mg is well-tolerated1,2.

TT3 has been remarkably successful in the management of newly diagnosed MM, inducing CR
rates of >60% and 4-year estimates of overall and event-free survival of 85% and 75%. Of
those achieving CR, estimated 4-year CR rate is 85%. TT3 maintenance has been with either
VTD in 2003-33 or VRD in 2006-66, so that pomalidomide's role in overcoming refractoriness
to lenalidomide can be assessed.

Pharmacogenomic investigations comparing GEP data obtained at baseline and 48hr
post-treatment have been performed in case of thalidomide, dexamethasone, lenalidomide,
bortezomib and melphalan3. Thus, as most patients on TT3 had baseline and 48-hr GEP
investigations performed after bortezomib, the opportunity exists to investigate, at the
time of relapse, not only a re-challenge with bortezomib with 48hr GEP but also
pomalidomide's effect.

Participants will receive testing dosing of Revlimid 25mg for 2 days followed by GEP
sampling. A washout period of at least 24 hours will follow Revlimid prior to starting
single agent Pomalidomide at 4 mg/day, days 1-21 every 28 days.

This is a phase II study, open-label, single institution trial of pomalidomide in
GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have
included lenalidomide.

Inclusion Criteria:

- Participant has multiple myeloma, relapsed or resistant to prior therapy.

- Participant has high-risk disease, as defined by any of the following:

- GEP risk score of > 0.66 OR

- Metaphase based abnormalities of 1q or 1p OR

- LDH > 360 U/L

- Participant has received prior therapy with lenalidomide-containing regimen and has
been determined to be refractory, resistant, or relapsed.

- Participant has no significant peripheral neuropathy (< grade 3 by the most current
NCI CTCAE version)

- Participant has adequate hematopoietic reserve as defined by platelet count ≥
50,000/µL and ANC of > 1000/µL.

- Participant has adequate renal function as defined by serum creatinine < 2 mg/dL.

- Participant has adequate hepatic function, defined by serum Total bilirubin mg/dL and AST (SGOT) and ALT (SGPT)
- Participant is 18 years of age or greater.

- Participant has not received anti-cancer therapy within 4 weeks prior to treatment on
this study.

- Zubrod ≤ 2, unless solely due to symptoms of MM-related bone disease.

- 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 - 14 days prior to
and again within 24 hours prior to starting lenalidomide or CC-4047 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 or

- All patients must be informed of the investigational nature of this study and must
sign and give written voluntary consent in accordance with institutional and federal

- Willing and able to take aspirin or alternate prophylactic anticoagulation.

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.

- Men unwilling to use a condom (even if they have undergone a prior vasectomy) while
having intercourse with any woman, while taking the drug and for 4 weeks after
stopping treatment.

- 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 lenalidomide.

- The development of erythema nodosum if characterized by a desquamating rash while
taking lenalidomide, CC-4047 or similar drugs.

- Any prior use of CC-4047.

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

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine are eligible.

- Active malignancy (exception of non melanoma skin cancer or in situ cervical or
breast cancer).

- Active DVT or PE that has not been therapeutically anticoagulated.

- ≥ grade 3 peripheral neuropathy.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) after initiation of pomalidomide therapy

Outcome Description:

Progression -free survival (PFS) after initiation of pomalidomide therapy

Outcome Time Frame:

1 year following initiation of pomalidomide therapy

Safety Issue:


Principal Investigator

Saad Usmani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy


United States: Institutional Review Board

Study ID:

UARK 2010-01



Start Date:

October 2011

Completion Date:

August 2013

Related Keywords:

  • Multiple Myeloma
  • Pomalidomide
  • multiple myeloma
  • relapsed
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy Little Rock, Arkansas  72205