Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Celgene Corporation
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01734928
First received: November 23, 2012
Last updated: February 27, 2015
Last verified: February 2015
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Purpose
The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone sodium phosphate
Pomalidomide
Dexamethasone acetate
Bortezomib
U.S. FDA Resources
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The length of time during and after the treatment that participants in the study live without the disease getting worse
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The length of time from start of study treatment that participants in the study are alive
- Adverse Event [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- Overall Response Rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The percentage of participants who respond to study treatment
- Duration of Response [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The length of time from when participants respond to the study treatment to when their disease gets worse
| Estimated Enrollment: | 782 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2021 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pomalidomide, Bortezomib and Low Dose Dexamethasone
4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.
|
Drug: Pomalidomide
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
Other Names:
Drug: Bortezomib
Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
Other Name: Velcade
Drug: Dexamethasone
Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
|
|
Active Comparator: Bortezomib and Low Dose Dexamethasone
1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
|
Drug: Bortezomib
Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
Other Name: Velcade
Drug: Dexamethasone
Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be ≥ 18yrs at the time of signing informed consent.
- Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
- Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
- Must have documented disease progression during or after their last anti-myeloma therapy.
- All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
Exclusion Criteria:
- Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule.
- Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
- Non-secretory multiple myeloma.
- Subjects with severe renal impairment requiring dialysis.
- Previous therapy with pomalidomide.
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: NCT01734928
Show 66 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734928
Contacts
| Contact: Eva Budz | 908-673-9576 | ebudz@celgene.com | |
| Contact: Jovanka Solorzano | 415-839-7016 | jsolorzano@celgene.com |
Show 66 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Amine Bensmaine, MD | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01734928 History of Changes |
| Other Study ID Numbers: | CC-4047-MM-007 |
| Study First Received: | November 23, 2012 |
| Last Updated: | February 27, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
Multiple Myeloma Pomalidomide |
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 |
Bortezomib 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 |
ClinicalTrials.gov processed this record on March 03, 2015