Know Cancer

or
forgot password

A Phase I-II Study of the Combination of Bendamustine and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase I-II Study of the Combination of Bendamustine and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Inclusion Criteria:



1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma

2. Relapsed or refractory to the most recently received therapy. Refractory disease is
defined as < 25% response or progression during therapy or within 60 days after
completion.

3. All patients must have received prior lenalidomide therapy and been determined to be
refractory. Refractory will be defined as a history of progression on a regimen
containing full or maximally tolerated dose of lenalidomide administered for a
minimum of at least two completed cycles of therapy.

4. Measurable disease as specified in the protocol

5. Prior to enrollment, sites must provide evidence of myeloma progression/relapse and
evidence of being refractory to lenalidomide, with start and stop dates of
lenalidomide therapy and the most recent treatment regimen, as well as best tumor
response to all prior treatment regimens.

6. Males and females 18 years of age or older

7. Life expectancy of more than 3 months

8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

9. Adequate hepatic function, with total bilirubin < 2 times the upper limit of normal
(ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3
times ULN

10. 10. Serum creatinine <3 mg/dL

11. Laboratory tests meet the levels specified in the protocol

12. Written informed consent in accordance with federal, local, and institutional
guidelines

13. Must meet requirements for pregnancy testing and use approved methods of
contraception

14. Patients must agree to take enteric coated aspirin 81 mg orally daily, or if history
of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or
be treated with full dose, low molecular weight heparin, as if to treat deep venous
thrombosis (DVT)/pulmonary embolism (PE)

Exclusion Criteria:

1. Patients with known sensitivity to any immunomodulatory drugs (IMiDs)

2. Use of any other experimental drugs or therapy within 21 days of screening

3. Exposure to any prior chemotherapy or steroids use within 14 days of screening
assessment. (steroids use allowed if necessary to treat spinal cord compression).

4. Any prior use of bendamustine.

5. Any prior use of pomalidomide.

6. Radiation therapy within 14 days of screening.

7. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).

8. Plasma cell leukemia.

9. Waldenström's macroglobulinemia.

10. Major surgery within 21 days prior to first dose.

11. Pregnant or lactating females.

12. Congestive heart failure (New York Heart Association class III to IV), symptomatic
ischemia, conduction abnormalities uncontrolled by conventional intervention or
myocardial infarction in the previous six months.

13. Uncontrolled hypertension

14. Acute active infection requiring systemic antibiotics, antivirals, or antifungals
within 14 days prior to first dose.

15. Patients receiving active treatment or intervention for any other malignancy or
patients who, at the investigator's discretion, may require active treatment or
intervention for any other malignancy within 8 months of starting study treatment.

16. Serious psychiatric or medical conditions that could interfere with treatment

17. Significant neuropathy (Grade 3, Grade 4) at the time of the first dose and/or within
14 days before enrollment

18. Contraindication to any of the required concomitant drugs, including, including
proton pump inhibitor (e.g. lansoprazole), enteric coated aspirin or if a history of
prior thrombotic disease, warfarin or low molecular weight heparin

19. Patients with primary systemic amyloidosis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose level

Outcome Description:

In the phase I dose escalation portion, patients will be sequentially enrolled in cohorts of 4 at dose levels defined in section 3.1 in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). Up to 24 patients will be enrolled in phase I portion.

Outcome Time Frame:

4 weeks after starting the study drug

Safety Issue:

Yes

Principal Investigator

Cristina Gasparetto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00040206

NCT ID:

NCT01754402

Start Date:

December 2012

Completion Date:

January 2023

Related Keywords:

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

Name

Location

Duke University Medical CenterDurham, North Carolina  27710