Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712789
Recruitment Status : Active, not recruiting
First Posted : October 24, 2012
Last Update Posted : October 22, 2018
Information provided by (Responsible Party):

Brief Summary:

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 682 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : November 6, 2012
Estimated Primary Completion Date : December 11, 2019
Estimated Study Completion Date : December 11, 2019

Arm Intervention/treatment
Experimental: Pomalidomide plus Dexamethasone
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
Drug: Pomalidomide
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle

Drug: Dexamethasone
Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 5 years ]
    Number of participants with adverse events

Secondary Outcome Measures :
  1. PK-Cmax [ Time Frame: Up to 5 years ]
    PK-Maximum Concentration in Plasma

  2. PK-AUC [ Time Frame: Up to 5 years ]
    PK-Area under the plasma concentration time curve

  3. PK-Cmin [ Time Frame: Up to 5 years ]
    PK-Minimum Concentration in Plasma

  4. Overall response rate [ Time Frame: Up to 5 years ]
    Rate of participants who responds to the study treatment

  5. Time to response [ Time Frame: Up to 5 years ]
    Time from study enrollment to first documented response

  6. Duration of response [ Time Frame: Up to 5 years ]
    Time from the treatment response until progression of Multiple Myeloma

  7. Progression-free survival [ Time Frame: Up to 5 years ]
    Time from enrollment until progression of Multiple Myeloma

  8. Time to progression [ Time Frame: Up to 5 years ]
    Time from study enrollment until progression to Multiple Myeloma

  9. Overall survival [ Time Frame: Up to 5 years ]
    Time from study enrollment to the death of the patient

  10. POM population pharmacokinetics and exposure-response [ Time Frame: During the first 6 cycles of treatment ]
    The key exposure data are serum drug concentration, Cmax, Cmin and AUC derived from the population PK analysis.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.
  • Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
  • Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
  • Patients must have either refractory or relapsed and refractory disease.
  • Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
  • Patients must have received adequate alkylator therapy

Exclusion Criteria:

  • Prior history of malignancies, other than Multiple Myeloma.
  • Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
  • Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
  • Patients who are planning for or who are eligible for stem cell transplant.
  • Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
  • Patients with a current disease that can interfere with protocol procedures or study treatment.
  • Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
  • Pregnant or breastfeeding females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712789

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Sponsors and Collaborators
Study Director: Tsvetan Biyukow, MD Celgene

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Celgene Identifier: NCT01712789     History of Changes
Other Study ID Numbers: CC-4047-MM-010
2012-001888-78 ( EudraCT Number )
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Keywords provided by Celgene:
Multiple Myeloma
Relapsed Multiple Myeloma
Relapsed and refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents