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A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma


PRIMARY OBJECTIVES:

I. Determine the response rate in patients with relapsed or refractory multiple myeloma
treated with flavopiridol.

II. Determine the disease-free survival and overall survival of patients treated with this
drug.

III. Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation
status, and BCRP expression in patients treated with this drug.

IV. Correlate disease response and drug treatment with cell cycle status and effects on
apoptosis and apoptosis regulatory proteins in these patients.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for
up to 12 months in the absence of disease progression or unacceptable toxicity. After 12
months, patients achieving at least a partial response may continue treatment in the absence
of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 1 year.


Inclusion Criteria:



- Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment

- Durie-Salmon stage I or greater at diagnosis

- Patients with non-secretory or oligo-secretory MM (defined as maximum
urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less
than 0.5 g/dL during entire disease course) must have at least 30% bone
marrow plasma cells

- Patients with secretory MM must have measurable disease defined as serum
monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200
mg/24 hours

- Must have received at least 1, but no more than 5 prior therapy regimens

- Patients who have had 4 or 5 regimens are allowed provided corticosteroids
and/or thalidomide are part of the regimens

- No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone
or thalidomide)

- Prior autologous peripheral blood stem cell transplantation is considered 1
prior regimen

- Performance status - ECOG 0-2

- Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g.,
vertebral compression or rib fracture)

- Absolute neutrophil count at least 750/mm^3

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

- AST no greater than 2.5 times ULN

- Creatinine no greater than 3 mg/dL

- No myocardial infarction within the past 6 months

- Peripheral neuropathy secondary to prior drug therapy or myeloma-associated
neuropathy allowed

- No other uncontrolled serious medical condition

- No uncontrolled infection

- No other active malignancy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- See Disease Characteristics

- No prior allogeneic stem cell transplantation

- At least 10 days since prior thalidomide

- No concurrent biologic therapy

- See Disease Characteristics

- At least 2 weeks since prior myelosuppressive chemotherapy

- No other concurrent chemotherapy

- See Disease Characteristics

- No concurrent corticosteroids (including as antiemetics) except chronic
corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or
adrenal insufficiency)

- Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone
no more than 40 mg/day

- At least 10 days since prior bortezomib or tipifarnib

- Concurrent bisphosphonates allowed if on stable dose before study entry

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.

Outcome Description:

Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.

Outcome Time Frame:

First 3 months of treatment

Safety Issue:

No

Principal Investigator

Angela Dispenzieri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02496

NCT ID:

NCT00047203

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Mayo Clinic Rochester, Minnesota  55905