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.
Verified November 2012 by Celgene Corporation
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01712789
First received: October 22, 2012
Last updated: November 19, 2012
Last verified: November 2012
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Pomalidomide
U.S. FDA Resources
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: Yes ]Rate of participants who responds to the study treatment
- Time to response [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Time from study enrollment to first documented response
- Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Time from the treatment response until progression of Multiple Myeloma
- Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Number of participants who survive without progressing
- Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Time from study enrollment until progression to Multiple Myeloma
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Number of participants who survive
| Estimated Enrollment: | 507 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2019 |
| Estimated Primary Completion Date: | November 2019 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712789
Show 85 Study Locations
Contacts
| Contact: Heike Niederbröker, PhD | +41 32 729 8738 | hniederbroeker@celgene.com |
Show 85 Study LocationsSponsors 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: | November 19, 2012 |
| 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 Finland: Finnish Medicines Agency 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) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Switzerland: Swissmedic 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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 19, 2013