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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01712789
First received: October 22, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Pomalidomide
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Secondary Outcome Measures:
  • PK-Cmax [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PK-Maximum Concentration in Plasma

  • PK-AUC [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PK-Area under the plasma concentration time curve

  • PK-Cmin [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PK-Minimum Concentration in Plasma

  • Overall response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Rate of participants who responds to the study treatment

  • Time to response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time from study enrollment to first documented response

  • Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time from the treatment response until progression of Multiple Myeloma

  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time from enrollment until progression of Multiple Myeloma

  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time from study enrollment until progression to Multiple Myeloma

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time from study enrollment to the death of the patient

  • POM population pharmacokinetics and exposure-response [ Time Frame: During the first 6 cycles of treatment ] [ Designated as safety issue: No ]
    The key exposure data are serum drug concentration, Cmax, Cmin and AUC derived from the population PK analysis.


Estimated Enrollment: 720
Study Start Date: November 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomalidomide plus Dexamethasone 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712789

Contacts
Contact: Heike Niederbröker, PhD +41 32 729 8738 hniederbroeker@celgene.com

  Show 119 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Nicolas Leupin, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01712789     History of Changes
Other Study ID Numbers: CC-4047-MM-010, 2012-001888-78
Study First Received: October 22, 2012
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Health and Medicines Authority
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Celgene Corporation:
Multiple Myeloma
Relapsed Multiple Myeloma
Relapsed and refractory Multiple Myeloma
Pomalidomide
Dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Pomalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 21, 2014