Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
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| ClinicalTrials.gov Identifier: NCT02272803 |
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Recruitment Status :
Active, not recruiting
First Posted : October 23, 2014
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan |
| Actual Study Start Date : | January 22, 2015 |
| Actual Primary Completion Date : | February 9, 2017 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
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 Drug: Dexamethasone Tablets, Oral 28 mg and 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 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 Biological: Elotuzumab (BMS-901608) 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 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 |
Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608) |
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Active Comparator: Arm B: 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 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 |
Drug: Lenalidomide Drug: Dexamethasone |
- Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]
ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
- Objective Response Rate (ORR) in All Treated Participants [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]
ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
- Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy [ Time Frame: From randomization to the date of first documented tumor progression or death due to any cause (assessed up to February 2017, approximately 24 months) ]PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
- PFS Rate at 1 Year [ Time Frame: 1 year ]The number of participants with PFS at 1 year post-randomization was divided by the total number randomized in that arm and expressed as a percentage. PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Newly diagnosed with symptomatic Multiple Myeloma (MM)
- Have not received any prior systemic anti-myeloma therapy
- Have measurable disease
- 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 CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria:
- Non-secretory 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
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 ClinicalTrials.gov identifier (NCT number): NCT02272803
| Japan | |
| Local Institution | |
| Nagoya-shi, Aichi, Japan, 4600001 | |
| Local Institution | |
| Nagoya-shi, Aichi, Japan, 4678602 | |
| Local Institution | |
| Aomori-shi, Aomori, Japan, 0308553 | |
| Local Institution | |
| Chiba-shi, Chiba, Japan, 2608677 | |
| Local Institution | |
| Kamogawa-shi, Chiba, Japan, 2968602 | |
| Local Institution | |
| Matsuyama-shi, Ehime, Japan, 7900024 | |
| Local Institution | |
| Fukuoka-shi, Fukuoka, Japan, 8128582 | |
| Local Institution | |
| Maebashi-shi, Gunma, Japan, 3718511 | |
| Local Institution | |
| Shibukawa-shi, Gunma, Japan, 3770280 | |
| Local Institution | |
| Fukuyama-shi, Hiroshima, Japan, 7200001 | |
| Local Institution | |
| Kasama-shi, Ibaraki, Japan, 3091793 | |
| Local Institution | |
| Morioka-shi, Iwate, Japan, 0208505 | |
| Local Institution | |
| Kagoshima-shi, Kagoshima, Japan, 8920853 | |
| Local Institution | |
| Kyoto-shi, Kyoto, Japan, 6028566 | |
| Local Institution | |
| Sendai-shi, Miyagi, Japan, 9808574 | |
| Local Institution | |
| Niigata-shi, Niigata, Japan, 9518566 | |
| Local Institution | |
| Okayama-shi, Okayama, Japan, 7011192 | |
| Local Institution | |
| Osaka-shi, Osaka, Japan, 5300012 | |
| Local Institution | |
| Osaka-shi, Osaka, Japan, 5438555 | |
| Local Institution | |
| Kawagoe-shi, Saitama, Japan, 3508550 | |
| Local Institution | |
| Hamamatsu-shi, Shizuoka, Japan, 4313192 | |
| Local Institution | |
| Utsunomiya-shi, Tochigi, Japan, 3200834 | |
| Local Institution | |
| Bunkyo-ku, Tokyo, Japan, 1138677 | |
| Local Institution | |
| Koto-ku, Tokyo, Japan, 1358550 | |
| Local Institution | |
| Shibuya-ku, Tokyo, Japan, 1508935 | |
| Local Institution | |
| Shinjuku-Ku, Tokyo, Japan, 1608582 | |
| Local Institution | |
| Shinjuku-ku, Tokyo, Japan, 1628655 | |
| Local Institution | |
| Tachikawa-shi, Tokyo, Japan, 1900014 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02272803 History of Changes |
| Other Study ID Numbers: |
CA204-116 |
| First Posted: | October 23, 2014 Key Record Dates |
| Results First Posted: | March 22, 2018 |
| Last Update Posted: | March 22, 2018 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | Yes | |
Additional relevant MeSH terms:
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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 Lenalidomide Thalidomide BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |