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Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma

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Trial Information

Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma


I. To evaluate the efficacy (overall response rate) of single agent SCH 727965 in patients
with relapsed or refractory multiple myeloma.


I. To evaluate the toxicities associated with use of single agent SCH 727965 in patients
with relapsed or refractory multiple myeloma.

II. To evaluate the response duration and progression free survival among patients with
relapsed or refractory multiple myeloma undergoing treatment with single agent SCH 727965.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected periodically for correlative studies. (US sites

After completion of study treatment, patients are followed up for up to 3 years.

Inclusion Criteria:

- Relapsed or refractory multiple myeloma

- Measurable disease as defined by at least ONE of the following:

- Serum monoclonal protein >= 1.0 g/dL

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

- Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio

- ≤ 5 prior therapies; stem cell transplantation and preceding induction therapy will
be considered as one therapy; NOTE: Patients must not be candidates for stem cell
transplantation or should have had stem cells collected previously

- Life expectancy of ≥ 3 months

- ECOG performance status of 0, 1 or 2

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 75,000/mcL

- Hemoglobin >= 8 g/dL

- Total serum bilirubin within normal institutional limits

- AST (SGOT)/ALT(SGPT) =< 2.5 X institutional ULN

- Creatinine < 2.5 mg/dL

- Negative serum pregnancy test done ≤7 days prior to registration (for women of
childbearing potential only); NOTE: Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

- Ability to understand and the willingness to sign a written informed consent document

- Willingness to provide blood and bone marrow samples for mandatory research component
of this study; (US sites only)

Exclusion Criteria:

- Any of the following prior therapies:

- Myelosuppressive therapy for myeloma ≤ 3 weeks prior to registration or those
who have not recovered from acute reversible adverse events due to agents
administered > 3 weeks earlier

- Non-myelosuppressive agents like thalidomide or high dose corticosteroids ≤ 2
weeks prior to registration

- Receiving any other investigational agents

- Concomitant high dose corticosteroids

- NOTE: Concurrent use of corticosteroids, but patients may be on chronic steroids
(maximum dose 20 mg/day prednisone equivalent) if they are being given for
disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis,

- NOTE: Bisphosphonates are considered to be supportive care rather than therapy,
and are thus allowed while on protocol treatment

- Active malignancy with the exception of non melanoma skin cancer or in situ cervical
or breast cancer

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infections or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or nursing women; NOTE: Because there is an unknown but potential risk for
adverse events in nursing infants secondary to treatment of the mother with SCH
727965, breastfeeding should be discontinued if the mother is treated with SCH 727965

- Currently taking inhibitors/inducers of CYP3A4; (SCH 727965 metabolizes via the
CYP3A4 enzyme; there are potential drug interactions with concomitant use of CYP3A4
potent inhibitors/inducers; Principal Investigator should review each case and
determine if patients on the CYP3A4 potent inhibitors/inducers are eligible and will
make all effort to switch to alternative drugs; patients should not take grapefruit/
grapefruit juice or St. Johns' Wort)

- Men or women of childbearing potential who are unwilling to employ adequate

Type of Study:


Study Design:

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

Outcome Measure:

Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.

Outcome Description:

Complete Response (CR): Negative immunofixation of serum and urine Normalization of FLC ratio < 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas Stringent Complete Response (sCR): CR, as above, with absence of clonal cells in bone marrow Partial Response (PR): One of the following: A ≥ 50% reduction of measurable serum M-protein. A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h. A ≥ 50% decrease in the difference between involved and uninvolved FLC levels. ≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30% A ≥50% reduction in the size of soft tissue plasmacytomas. Very Good Partial Response (VGPR): PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Shaji Kumar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

December 2011

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mayo ClinicRochester, Minnesota  55905