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A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis


OBJECTIVES:

- To assess the response rate and duration of remission with low-dose CC-4047 plus
dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis.

- To assess the toxicity of CC-4047 plus dexamethasone in this patient population.

- To assess in an expansion cohort the response rate with an increase in CC-4047 dose
among patients who fail to respond adequately to the initial starting dose following
the first 2 courses of treatment.

- To assess the response rate and duration of remission with CC-4047 plus dexamethasone
in patients with lenalidomide resistant or refractory multiple myeloma.

- To assess the response rate and duration of remission with CC-4047 plus dexamethasone
in patients with previously treated light chain amyloidosis.

- To assess the response rate and duration of remission with low- and high-dose CC-4047
plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple
myeloma.

- To assess the response rate and duration of remission with high-dose CC-4047 plus
dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3
treatment regimens.

OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma
[closed to accrual as of 8/5/2008] vs lenalidomide resistant/refractory myeloma [closed to
accrual as of 4/2/2009] vs previously treated light chain amyloidosis vs lenalidomide and
bortezomib resistant/refractory myeloma {low-dose/day}[closed to accrual as of 11/20/09] vs
lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs
relapsed/refractory myeloma {high-dose/day}).

Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed for 4 weeks and then at 6 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Symptomatic multiple myeloma

- Previously treated disease meeting one of the following criteria:

- Have light-chain amyloidosis that has been treated with at least one prior
regimen

- Symptomatic (relapsed or refractory) multiple myeloma

- Patients must have received 1-3 treatment regimens

- Induction therapy followed by autologous stem cell transplantation and
consolidation considered one regimen

- Measurable disease, as defined by 1 of the following:

- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

- More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis

- Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio

- Measurable soft tissue plasmacytoma, not previously irradiated

- More than 30% plasma cells in bone marrow

- At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or
labeling index

- No monoclonal gammopathy of undetermined significance (not applicable for patients
with amyloid)

- No smoldering myeloma (not applicable for patients with amyloid)

PATIENT CHARACTERISTICS:

- ECOG performance status 0, 1, or 2

- ANC ≥ 1,000/μL

- Platelet count ≥ 75,000/μL

- Creatinine ≤ 2.5 mg/dL

- Not pregnant or nursing

- Women must refrain from breastfeeding during study participation and for at
least 28 days after discontinuation of study drug

- Negative pregnancy test

- Fertile female patients must use two reliable forms of contraception simultaneously
at least 28 days before beginning, during, and at least 28 days after completion of
study drug

- The two methods of reliable contraception must include one highly effective
method (i.e., intrauterine device [IUD], hormonal [birth control pills,
injections, or implants], tubal ligation, or partner's vasectomy) and one
additional effective (barrier) method (i.e., latex condom, diaphragm, or
cervical cap)

- Fertile male patients must use a latex condom (even if they have undergone a prior
vasectomy) while having intercourse with any woman, while taking the drug and for 28
days after stopping treatment

- Men must agree to abstain from donating semen or sperm during study participation and
for 28 days after discontinuation of study drug

- Willing to abstain from donating blood during study participation and for 28 days
after discontinuation of study drug

- No uncontrolled infection

- No other active malignancy

- No New York Heart Association class III or IV cardiac disease (all patients)

- Serum troponin T > 0.10 ng/mL (amyloid patients only)

- No known positivity for HIV or active hepatitis infection

- No active deep vein thrombosis or pulmonary embolism that has not been
therapeutically anticoagulated

- No condition, including the presence of laboratory abnormalities, that places the
patient at unacceptable risk for participating in the study or confounds the ability
to interpret data from the study

- No known hypersensitivity to thalidomide or lenalidomide including development of
erythema nodosum if characterized by a desquamating rash

- No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

- All previous cancer therapy, including chemotherapy and investigational agents, must
have been discontinued ≥ 2 weeks prior to study registration

- No radiotherapy ≤ 14 days prior to study registration

- No other concurrent anti-myeloma therapy

- No concurrent radiotherapy, except for palliation of a single painful bone lesion or
fracture

- Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone
disease

- Willing and able to take aspirin or alternate prophylactic anticoagulation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of confirmed responses (complete, partial, or very good partial response)

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Martha Q. Lacy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000574742

NCT ID:

NCT00558896

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224