Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)
This study is currently recruiting participants.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335399
First received: April 13, 2011
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608; HuLuc63) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. [ Time Frame: Every 4 weeks (-1/+3 days) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ] [ Designated as safety issue: No ]
- Overall Survival - The period of time from study entry until the date of death or last known date alive. [ Time Frame: Survival will be assessed every 16 weeks in the Follow Up Phase of the trial. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | November 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lenalidomide + Dexamethasone |
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®
Drug: Dexamethasone
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
|
| Experimental: Lenalidomide + Dexamethasone + Elotuzumab |
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®
Drug: Dexamethasone
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria:
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335399
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Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham Hematology & Oncology Associates Llc | Recruiting |
| Birmingham, Alabama, United States, 35213 | |
| Contact: Kevin S Windsor, Site 1628 205-592-5077 | |
| United States, Arizona | |
| Acrc/Arizona Clinical Research Center, Inc. | Recruiting |
| Tucson, Arizona, United States, 85715 | |
| Contact: Manuel R Modiano, Site 1644 520-290-2510 | |
| United States, California | |
| Local Institution | Not yet recruiting |
| Bakersfield, California, United States, 93309 | |
| Contact: , Site 1618 | |
| Alta Bates Summit Comprehensive Cancer Center | Recruiting |
| Berkeley, California, United States, 94704 | |
| Contact: Rajesh Behl, Site 1602 510-204-6401 | |
| Compassionate Cancer Care Medical Group Inc | Recruiting |
| Corona, California, United States, 92879 | |
| Contact: Haresh S Jhangiani, Site 1668 951-371-2411 | |
| Compassionate Cancer Care Medical Group Inc | Recruiting |
| Corona, California, United States, 92879 | |
| Contact: Haresh S Jhangiani, Site 1636 951-371-2411 | |
| Marin Cancer Care, Inc | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: Peter D. Eisenberg, Site 1616 415-925-5000 | |
| Local Institution | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Site 1660 | |
| Medical Oncology Care Associates | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Birbal Bhaskar, Site 1673 714-541-6622 | |
| Sharp Clinical Oncology Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Rajesh Belani, Site 1613 858-939-5062 | |
| United States, Connecticut | |
| Yale University School Of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Madhav V Dhodapkar, Site 1621 203-785-2604 | |
| United States, District of Columbia | |
| Washington Cancer Institute At Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Joseph P Catlett, Site 1612 202-877-8839 | |
| United States, Florida | |
| Cancer Care Centers Of Florida | Recruiting |
| Brooksville, Florida, United States, 34613 | |
| Contact: Raju Rao, Site 1617 352-596-1401 | |
| Florida Cancer Specialists | Recruiting |
| Fort Myers, Florida, United States, 33916 | |
| Contact: James Andrew Jr Reeves, Site 1648 239-275-6400 | |
| Integrated Community Oncology Network | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Contact: Mehdi M Moezi, Site 1623 904-272-3139 | |
| Cancer Care Centers Of Florida | Recruiting |
| New Port Richey, Florida, United States, 34652 | |
| Contact: Kapisthalam S. Kumar, Site 1625 727-842-2795 | |
| Florida Cancer Specialists | Recruiting |
| St. Petersburg, Florida, United States, 33705 | |
| Contact: Peter Acs, Site 1649 352-332-3900 | |
| Palm Beach Cancer Institute | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Shachar Peles, Site 1611 561-366-4112 | |
| United States, Georgia | |
| Local Institution | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Site 1630 | |
| United States, Illinois | |
| The University Of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Cara Rosenbaum, Site 1607 773-702-0167 | |
| Local Institution | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Site 1635 | |
| United States, Indiana | |
| Investigative Clinical Research Of Indiana, Llc | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Robert F Manges, Site 1669 317-297-2208 | |
| Michiana Hematology Oncology, P.C. | Recruiting |
| Mishawaka, Indiana, United States, 46545 | |
| Contact: Jose A Bufill, Site 1656 574-234-5123 | |
| United States, Iowa | |
| University Of Iowa Hospitals And Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Raymond Hohl, Site 1633 319-356-8110 | |
| United States, Kentucky | |
| Local Institution | Not yet recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact: Site 1674 | |
| Local Institution | Not yet recruiting |
| Louisville, Kentucky, United States, 40207 | |
| Contact: Site 1683 | |
| Local Institution | Not yet recruiting |
| Pikeville, Kentucky, United States, 41501 | |
| Contact: , Site 1666 | |
| United States, Louisiana | |
| Cancer Center Of Acadiana At Lafayette General | Recruiting |
| Lafayette, Louisiana, United States, 70503 | |
| Contact: Luis A Meza, Site 1646 337-289-8400 | |
| Local Institution | Not yet recruiting |
| Shreveport, Louisiana, United States, 71103 | |
| Contact: Site 1652 | |
| United States, Maryland | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: , Site 1676 443-849-2000 | |
| Harry & Jeanette Weinberg Cancer Institute | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Stephen Noga, Site 1650 443-777-7452 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Jacob Laubach, Site 1619 617-632-2104 | |
| Local Institution | Not yet recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Site 1606 | |
| United States, Michigan | |
| Local Institution | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Site 1603 | |
| University Of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 49109 | |
| Contact: Mark Kaminski, Site 1681 734-939-5310 | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Philip Kuriakose, Site 1604 313-916-1784 | |
| United States, Missouri | |
| Columbia Comprehensive Cancer Care Clinic | Recruiting |
| Jefferson City, Missouri, United States, 65109 | |
| Contact: Ali Khojasteh, Site 1667 573-556-7788 | |
| Mercy Medical Research Institute | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Viran Roger Holden, Site 1651 417-820-8099 | |
| Washington University School Of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Keith Stockerl-Goldstein, Site 1645 314-454-8304 | |
| United States, New York | |
| Local Institution | Not yet recruiting |
| New York, New York, United States, 10016 | |
| Contact: Site 1622 | |
| Local Institution | Not yet recruiting |
| New York, New York, United States, 10003 | |
| Contact: , Site 1699 | |
| St. Luke'S Roosevelt Hospital Center | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Peter Wiernik, Site 1692 212-636-3334 | |
| St. Luke'S-Roosevelt Hospital Center | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Peter Wiernik, Site 1615 212-636-3338 | |
| Local Institution | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Contact: Site 1689 | |
| Stony Brook University Medical Center | Recruiting |
| Stony Brook, New York, United States, 11794-8151 | |
| Contact: Michael W Schuster, Site 1671 631-444-3577 | |
| United States, North Carolina | |
| Mecklenburg Medical Group | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: David W Miller, Site 1605 704-302-9040 | |
| Piedmont Hematology Oncology Associates, Pa | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Franklin L. Chen, Site 1610 336-277-8887 | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Christy Stotler, Site 1608 216-444-0293 | |
| Benson, Md, Don | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Don Benson, Site 1638 740-296-8508 | |
| Local Institution | Not yet recruiting |
| Middletown, Ohio, United States, 45042 | |
| Contact: Site 1690 | |
| United States, Oklahoma | |
| Cancer Care Associates | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Charles M Strnad, Site 1655 918-499-2000 | |
| United States, Pennsylvania | |
| Local Institution | Not yet recruiting |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Contact: Site 1665 | |
| Local Institution | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Site 1647 | |
| Local Institution | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Contact: , Site 1679 | |
| United States, South Carolina | |
| Charleston Hematology Oncology Associates, Pa | Recruiting |
| Charleston, South Carolina, United States, 29414 | |
| Contact: George F. Geils Jr, Site 1629 843-577-6957 | |
| Local Institution | Not yet recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Site 1624 | |
| United States, Tennessee | |
| Tennessee Cancer Specialists | Recruiting |
| Knoxville, Tennessee, United States, 37909 | |
| Contact: Tracy W. Dobbs, Site 1600 865-934-2670 | |
| Tennessee Oncology, Pllc | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Jesus Berdeja, Site 1627 615-986-7600 | |
| United States, Texas | |
| Cancer Specialists Of South Texas, Pa | Recruiting |
| Corpus Christi, Texas, United States, 78412 | |
| Contact: Aftab Mahmood, Site 1634 361-993-3456 | |
| The University Of Texas Md Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jatin Shah, Site 1614 713-792-2817 | |
| Northwest Cancer Center | Recruiting |
| Houston, Texas, United States, 77090 | |
| Contact: Laurent Gressot, Site 1642 281-440-5006 | |
| United States, Virginia | |
| Hematology-Oncology Associates Of Fredricksburg, Inc | Recruiting |
| Fredricksburg, Virginia, United States, 22408 | |
| Contact: Christopher Vaughn, Site 1657 540-371-0079 | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Beata Holkova, Site 1620 804-628-2581 | |
| United States, Washington | |
| Local Institution | Not yet recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Site 1640 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: William Bensinger, Site 1631 206-667-4933 | |
| United States, West Virginia | |
| Edwards Comprehensive Cancer Center | Recruiting |
| Huntington, West Virginia, United States, 25701 | |
| Contact: Rajesh Sehgal, Site 1601 304-399-6610 | |
| United States, Wisconsin | |
| Gundersen Clinic, Ltd | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Craig E Cole, Site 1653 608-782-7300 | |
| Local Institution | Not yet recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Site 1609 | |
| Dean Clinic-Hematology And Oncology | Recruiting |
| Madison, Wisconsin, United States, 53717 | |
| Contact: Amit Sanyal, Site 1663 608-410-2700 | |
| Australia, New South Wales | |
| Local Institution | Recruiting |
| Waratah, New South Wales, Australia, 2298 | |
| Contact: Site 3607 | |
| Local Institution | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Site 3610 | |
| Australia, Queensland | |
| Local Institution | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Contact: Site 3609 | |
| Local Institution | Recruiting |
| South Brisbane, Queensland, Australia, 4101 | |
| Contact: Site 3608 | |
| Australia, South Australia | |
| Local Institution | Recruiting |
| Adelaide, South Australia, Australia, 5011 | |
| Contact: Site 3606 | |
| Local Institution | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Site 3612 | |
| Australia, Victoria | |
| Local Institution | Recruiting |
| Fitzroy, Victoria, Australia, 3065 | |
| Contact: Site 3601 | |
| Local Institution | Recruiting |
| Frankston, Victoria, Australia, 3199 | |
| Contact: Site 3602 | |
| Local Institution | Recruiting |
| Heidelberg Melbourne, Victoria, Australia, 3084 | |
| Contact: Site 3603 | |
| Local Institution | Recruiting |
| Wodonga, Victoria, Australia, 3690 | |
| Contact: Site 3604 | |
| Australia, Western Australia | |
| Local Institution | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Contact: Site 3611 | |
| Local Institution | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: Site 3605 | |
| Australia | |
| Local Institution | Recruiting |
| Canberra, Australia, 2605 | |
| Contact: Site 3600 | |
| Austria | |
| Local Institution | Recruiting |
| Innsbruck, Austria, 6020 | |
| Contact: Site 4051 | |
| Local Institution | Recruiting |
| Linz, Austria, 4020 | |
| Contact: Site 4052 | |
| Local Institution | Recruiting |
| Rankweil, Austria, 6830 | |
| Contact: Site 4054 | |
| Local Institution | Recruiting |
| Wels, Austria, 4600 | |
| Contact: Site 4053 | |
| Local Institution | Recruiting |
| Wien, Austria, 1090 | |
| Contact: Site 4050 | |
| Belgium | |
| Local Institution | Recruiting |
| Brussels, Belgium, 1020 | |
| Contact: Site 4160 | |
| Local Institution | Recruiting |
| Brussels, Belgium, 1090 | |
| Contact: Site 4156 | |
| Local Institution | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Site 4152 | |
| Local Institution | Recruiting |
| Brussles, Belgium, 1200 | |
| Contact: Site 4157 | |
| Local Institution | Recruiting |
| Charleroi, Belgium, 6000 | |
| Contact: Site 4154 | |
| Local Institution | Recruiting |
| Edegem-Antwerp, Belgium, 2650 | |
| Contact: Site 4155 | |
| Local Institution | Recruiting |
| Haine St Paul, Belgium, 7100 | |
| Contact: Site 4159 | |
| Local Institution | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Site 4158 | |
| Local Institution | Recruiting |
| Liege, Belgium, 4000 | |
| Contact: Site 4150 | |
| Local Institution | Recruiting |
| Roeselare, Belgium, 8800 | |
| Contact: Site 4153 | |
| Local Institution | Recruiting |
| Yvoir, Belgium, 5530 | |
| Contact: Site 4151 | |
| Canada, Alberta | |
| Local Institution | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Contact: Site 2601 | |
| Local Institution | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Site 2600 | |
| Canada, Manitoba | |
| Local Institution | Not yet recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Site 2602 | |
| Canada, New Brunswick | |
| Local Institution | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Site 2611 | |
| Canada, Nova Scotia | |
| Local Institution | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Contact: Site 2610 | |
| Canada, Ontario | |
| Local Institution | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Site 2606 | |
| Local Institution | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Site 2612 | |
| Local Institution | Not yet recruiting |
| Weston, Ontario, Canada, M9N 1N8 | |
| Contact: Site 2608 | |
| Canada, Quebec | |
| Local Institution | Not yet recruiting |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Contact: Site 2603 | |
| Local Institution | Recruiting |
| Montral, Quebec, Canada, H3A 1A1 | |
| Contact: Site 2607 | |
| Local Institution | Not yet recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Site 2605 | |
| Canada, Saskatchewan | |
| Local Institution | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Site 2604 | |
| Czech Republic | |
| Local Institution | Recruiting |
| Hradec Kralove, Czech Republic, 500 05 | |
| Contact: Site 4252 | |
| Local Institution | Recruiting |
| Praha 10, Czech Republic, 100 34 | |
| Contact: Site 4250 | |
| Local Institution | Not yet recruiting |
| Praha 2, Czech Republic, 128 08 | |
| Contact: Site 4251 | |
| Germany | |
| Local Institution | Recruiting |
| Aschaffenburg, Germany, 63739 | |
| Contact: Site 4565 | |
| Local Institution | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: Site 4550 | |
| Local Institution | Recruiting |
| Chemnitz, Germany, 09113 | |
| Contact: Site 4555 | |
| Local Institution | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Site 4562 | |
| Local Institution | Recruiting |
| Hamm, Germany, 59071 | |
| Contact: Site 4552 | |
| Local Institution | Recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Site 4553 | |
| Local Institution | Recruiting |
| Jena, Germany, 07747 | |
| Contact: Site 4560 | |
| Local Institution | Recruiting |
| Koln, Germany, 50937 | |
| Contact: Site 4563 | |
| Local Institution | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Site 4554 | |
| Local Institution | Recruiting |
| Munchen, Germany, 81377 | |
| Contact: Site 4561 | |
| Local Institution | Recruiting |
| Munster, Germany, 48149 | |
| Contact: Site 4558 | |
| Local Institution | Recruiting |
| Offenbach, Germany, 63069 | |
| Contact: Site 4551 | |
| Local Institution | Recruiting |
| Stuttgart, Germany, 70376 | |
| Contact: Site 4556 | |
| Local Institution | Recruiting |
| Tuebingen, Germany, 72076 | |
| Contact: Site 4564 | |
| Local Institution | Recruiting |
| Ulm, Germany, 89081 | |
| Contact: Site 4559 | |
| Greece | |
| Local Institution | Recruiting |
| Athens, Greece, 11528 | |
| Contact: Site 4651 | |
| Local Institution | Not yet recruiting |
| Athens, Greece, 11527 | |
| Contact: Site 4653 | |
| Local Institution | Recruiting |
| Ioannina, Greece, 45500 | |
| Contact: Site 4650 | |
| Local Institution | Recruiting |
| Larissa, Greece, 41110 | |
| Contact: Site 4652 | |
| Local Institution | Recruiting |
| Patras, Greece, 26504 | |
| Contact: Site 4654 | |
| Hungary | |
| Local Institution | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Site 4754 | |
| Local Institution | Terminated |
| Budapest, Hungary, 1097 | |
| Local Institution | Terminated |
| Debrecen, Hungary, 4032 | |
| Local Institution | Terminated |
| Gyor, Hungary, 9024 | |
| Local Institution | Terminated |
| Szeged, Hungary, 6720 | |
| Ireland | |
| Local Institution | Recruiting |
| Co Galway, Galway, Ireland | |
| Contact: Site 4851 | |
| Local Institution | Recruiting |
| Dublin, Ireland, 7 | |
| Contact: Site 4852 | |
| Local Institution | Recruiting |
| Dublin, Ireland, 8 | |
| Contact: Site 4850 | |
| Israel | |
| Local Institution | Recruiting |
| Afula, Israel, 18101 | |
| Contact: Site 4950 | |
| Local Institution | Recruiting |
| Ashkelon, Israel, 78278 | |
| Contact: Site 4956 | |
| Local Institution | Recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Site 4951 | |
| Local Institution | Recruiting |
| Nahariya, Israel, 22100 | |
| Contact: Site 4954 | |
| Local Institution | Recruiting |
| Petah Tikva, Israel, 49100 | |
| Contact: Site 4952 | |
| Local Institution | Recruiting |
| Rehovot, Israel, 76100 | |
| Contact: Site 4953 | |
| Local Institution | Recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Site 4957 | |
| Local Institution | Recruiting |
| Zerifin, Israel, 70300 | |
| Contact: Site 4955 | |
| Italy | |
| Local Institution | Recruiting |
| Ancona, Italy, 60126 | |
| Contact: Site 5067 | |
| Local Institution | Not yet recruiting |
| Bari, Italy, 70124 | |
| Contact: Site 5065 | |
| Local Institution | Recruiting |
| Bergamo, Italy, 24128 | |
| Contact: Site 5053 | |
| Local Institution | Recruiting |
| Bologna, Italy, 40138 | |
| Contact: Site 5070 | |
| Local Institution | Not yet recruiting |
| Catania, Italy, 95124 | |
| Contact: Site 5060 | |
| Local Institution | Recruiting |
| Firenze, Italy, 50134 | |
| Contact: Site 5066 | |
| Local Institution | Recruiting |
| Genova, Italy, 16132 | |
| Contact: Site 5050 | |
| Local Institution | Not yet recruiting |
| Giovanni Rotondo, Italy, 71013 | |
| Contact: Site 5059 | |
| Local Institution | Not yet recruiting |
| Lecce, Italy, 73100 | |
| Contact: Site 5061 | |
| Local Institution | Recruiting |
| Meldola, Italy, 47014 | |
| Contact: Site 5057 | |
| Local Institution | Recruiting |
| Milano, Italy, 20132 | |
| Contact: Site 5069 | |
| Local Institution | Recruiting |
| Monza, Italy, 20052 | |
| Contact: Site 5052 | |
| Local Institution | Recruiting |
| Napoli, Italy, 80131 | |
| Contact: Site 5068 | |
| Local Institution | Recruiting |
| Napoli, Italy, 80131 | |
| Contact: Site 5062 | |
| Local Institution | Recruiting |
| Palermo, Italy, 90146 | |
| Contact: Site 5055 | |
| Local Institution | Recruiting |
| Ravenna, Italy, 47923 | |
| Contact: Site 5063 | |
| Local Institution | Recruiting |
| Rimini, Italy, 47923 | |
| Contact: Site 5064 | |
| Local Institution | Recruiting |
| Roma, Italy, 00144 | |
| Contact: Site 5058 | |
| Local Institution | Recruiting |
| Roma, Italy, 00161 | |
| Contact: Site 5056 | |
| Local Institution | Recruiting |
| Roma, Italy, 00168 | |
| Contact: Site 5054 | |
| Local Institution | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Site 5051 | |
| Poland | |
| Local Institution | Recruiting |
| Bialystok, Poland, 15-276 | |
| Contact: Site 5250 | |
| Local Institution | Recruiting |
| Chorzow, Poland, 41-500 | |
| Contact: Site 5252 | |
| Local Institution | Not yet recruiting |
| Gdansk, Poland, 80-211 | |
| Contact: Site 5254 | |
| Local Institution | Not yet recruiting |
| Lodz, Poland, 93-510 | |
| Contact: Site 5258 | |
| Local Institution | Recruiting |
| Lublin, Poland, 20-081 | |
| Contact: Site 5257 | |
| Local Institution | Recruiting |
| Poznan, Poland, 60-569 | |
| Contact: Site 5259 | |
| Local Institution | Not yet recruiting |
| Szczecin, Poland, 70-111 | |
| Contact: Site 5255 | |
| Local Institution | Recruiting |
| Warsaw, Poland, 02-776 | |
| Contact: Site 5260 | |
| Local Institution | Recruiting |
| Warsaw, Poland, 02-106 | |
| Contact: Site 5256 | |
| Local Institution | Recruiting |
| Warszawa, Poland, 02-507 | |
| Contact: Site 5253 | |
| Local Institution | Recruiting |
| Wroclaw, Poland, 50-367 | |
| Contact: Site 5251 | |
| Puerto Rico | |
| Local Institution | Recruiting |
| Ponce, Puerto Rico, 00716 | |
| Contact: Site 7600 | |
| Local Institution | Not yet recruiting |
| San Juan, Puerto Rico, 00918 | |
| Contact: Site 7602 | |
| Romania | |
| Local Institution | Recruiting |
| Brasov, Romania, 500326 | |
| Contact: Site 5356 | |
| Local Institution | Recruiting |
| Bucaresti, Romania, 030171 | |
| Contact: Site 5350 | |
| Local Institution | Recruiting |
| Bucuresti, Romania, 020125 | |
| Contact: Site 5355 | |
| Local Institution | Recruiting |
| Bucuresti, Romania, 050098 | |
| Contact: Site 5353 | |
| Local Institution | Recruiting |
| Bucuresti, Romania, 22328 | |
| Contact: Site 5352 | |
| Local Institution | Recruiting |
| Lasi, Romania, 700106 | |
| Contact: Site 5351 | |
| Russian Federation | |
| Local Institution | Not yet recruiting |
| Moscow, Russian Federation, 115478 | |
| Contact: Site 5451 | |
| Local Institution | Recruiting |
| Samara, Russian Federation, 443095 | |
| Contact: Site 5453 | |
| Local Institution | Not yet recruiting |
| St Petersburg, Russian Federation, 197089 | |
| Contact: Site 5452 | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 197022 | |
| Contact: Site 5450 | |
| Spain | |
| Local Institution | Recruiting |
| Badalona-Barcelona, Spain, 08916 | |
| Contact: Site 5552 | |
| Local Institution | Recruiting |
| Barcelona, Spain, 08041 | |
| Contact: Site 5555 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Site 5551 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Site 5554 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28006 | |
| Contact: Site 5553 | |
| Local Institution | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact: Site 5550 | |
| Local Institution | Recruiting |
| San Sebastian, Spain, 20014 | |
| Contact: Site 5557 | |
| Local Institution | Recruiting |
| Toledo, Spain, 45004 | |
| Contact: Site 5556 | |
| Switzerland | |
| Local Institution | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Site 5751 | |
| Local Institution | Recruiting |
| St Gallen, Switzerland, 9007 | |
| Contact: Site 5750 | |
| Local Institution | Recruiting |
| Zurich, Switzerland, 8028 | |
| Contact: Site 5753 | |
| Local Institution | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Site 5752 | |
| Turkey | |
| Local Institution | Not yet recruiting |
| Adana, Balcali, Turkey, 01330 | |
| Contact: Site 5855 | |
| Local Institution | Not yet recruiting |
| Izmir, Bornova, Turkey, 35100 | |
| Contact: Site 5853 | |
| Local Institution | Not yet recruiting |
| Istanbul, Capa, Turkey, 34340 | |
| Contact: Site 5852 | |
| Local Institution | Not yet recruiting |
| Ankara, Demetevier, Turkey, 06310 | |
| Contact: Site 5850 | |
| Local Institution | Not yet recruiting |
| Ankara, Dikimevi, Turkey, 06620 | |
| Contact: Site 5851 | |
| Local Institution | Not yet recruiting |
| Izmir, Inciralti, Turkey, 35340 | |
| Contact: Site 5854 | |
| Local Institution | Not yet recruiting |
| Gaziantep, Turkey, 27310 | |
| Contact: Site 5856 | |
| United Kingdom | |
| Local Institution | Not yet recruiting |
| Belfast, Antrim, United Kingdom, BT9 7AB | |
| Contact: Site 5951 | |
| Local Institution | Recruiting |
| London, Greater London, United Kingdom, NW3 2QG | |
| Contact: Site 5955 | |
| Local Institution | Not yet recruiting |
| London, Greater London, United Kingdom, SE5 9RS | |
| Contact: Site 5953 | |
| Local Institution | Recruiting |
| London, Greater London, United Kingdom, NW1 2PG | |
| Contact: Site 5952 | |
| Local Institution | Recruiting |
| London, Greater London, United Kingdom, EC1A 7BE | |
| Contact: Site 5950 | |
| Local Institution | Recruiting |
| London, United Kingdom, HA1 3UJ | |
| Contact: Site 5954 | |
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01335399 History of Changes |
| Other Study ID Numbers: | CA204-006, 2010-022445-20 |
| Study First Received: | April 13, 2011 |
| Last Updated: | January 4, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Austria: Federal Office for Safety in Health Care Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Canada: Health Canada Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Germany: Paul-Ehrlich-Institut Germany: Federal Office for Radiation Protection Germany: Ministry of Health Greece: Ethics Committee Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Romania: Ministry of Public Health Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Spain: Spanish Agency of Medicines Switzerland: Federal Office of Public Health Switzerland: Swissmedic Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Newly Diagnosed Previously Untreated |
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 Lenalidomide 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 |
ClinicalTrials.gov processed this record on May 22, 2013