Multiple MyelomaPhase 2NCT02272803

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

A Phase 2 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 28 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 28 sitesJapan
Study dates: 20 Feb 2015to 21 Jul 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Japan28 sites

Local Institution
Aomori, Aomori, 0308553
Local Institution
Bunkyo-ku, Tokyo, 1138677
Local Institution
Chiba, Chiba, 2608677
Local Institution
Fukuoka, Fukuoka, 8128582
Local Institution
Fukuyama-shi, Hiroshima, 7200001
Local Institution
Hamamatsu, Shizuoka, 4313192
Local Institution
Kagoshima, Kagoshima-ken, 8920853
Local Institution
Kamogawa-shi, Chiba, 2968602
Local Institution
Kasama-shi, 3091793
Local Institution
Kawagoe-shi, Saitama, 3508550
Local Institution
Koto-ku, Tokyo, 1358550
Local Institution
Kyoto, Kyoto, 6028566
Local Institution
Maebashi, Gunma, 3718511
Local Institution
Matsuyama, Ehime, 7900024
Local Institution
Morioka, Iwate, 0208505
Local Institution
Nagoya, Aichi-ken, 4600001
Local Institution
Nagoya, Aichi-ken, 4678602
Local Institution
Niigata, Niigata, 9518566
Local Institution
Okayama, Okayama-ken, 7011192
Local Institution
Osaka, Osaka, 5300012
Local Institution
Osaka, Osaka, 5438555
Local Institution
Sendai, Miyagi, 9808574
Local Institution
Shibukawa-shi, Gunma, 3770280
Local Institution
Shibuya-ku, Tokyo, 1508935
Local Institution
Shinjuku-ku, Tokyo, 1628655
Local Institution
Shinjuku-Ku, Tokyo, 1608582
Local Institution
Tachikawa-shi, Tokyo, 1900014
Local Institution
Utsunomiya, Tochigi, 3200834

Other trials in Japan

About this study

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

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

Conditions: Multiple Myeloma
Being tested: Lenalidomide, Dexamethasone, Elotuzumab (BMS-901608)
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenalidomideDrug
DexamethasoneDrug
Elotuzumab (BMS-901608)Biological

Study groups in NCT02272803
Study group	Role	What they receive
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)	Experimental	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 Receives: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608)
Arm B: Lenalidomide + Dexamethasone	Active comparator	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 Receives: Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)
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.
Measured: From first dose until documented response (assessed up to February 2017, approximately 24 months)

Secondary outcomes (3)

Objective Response Rate (ORR)
ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (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.
Measured: From first dose until documented response, up to approximately 72 months
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (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.
Measured: From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
Progression Free Survival (PFS) Rate
PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints
Measured: From randomization up to the specified timepoints, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201521 Jul 2021

First posted23 Oct 2014 (estimated)
Study start20 Feb 2015
Primary completion9 Feb 2017
Study completion21 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02272803
Sponsor's protocol ID: CA204-116
Status last verified: May 2022
First submitted: 21 Oct 2014
Last updated: 22 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K. Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy. Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12. No abstract available.
PubMed 32398792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02272803
Acronym / sponsor ID: CA204-116
Conditions: Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: AbbVie
Study start: 20 Feb 2015 (actual)
Primary completion: 9 Feb 2017 (actual)
Study completion: 21 Jul 2021 (actual)
First posted: 23 Oct 2014 (estimated)
Results: Posted 22 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)	Experimental	Drug: Lenalidomide, Drug: Dexamethasone, Biological: 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
Arm B: Lenalidomide + Dexamethasone	Active comparator	Drug: Lenalidomide, Drug: DexamethasoneDrug: 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

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lenalidomide	Drug	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608), Arm B: Lenalidomide + Dexamethasone
Dexamethasone	Drug	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608), Arm B: Lenalidomide + Dexamethasone
Elotuzumab (BMS-901608)	Biological	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

Primary outcome

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.

3 secondary outcomes

Objective Response Rate (ORR)
Time frame: From first dose until documented response, up to approximately 72 months
Progression Free Survival (PFS)
Time frame: From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
Progression Free Survival (PFS) Rate
Time frame: From randomization up to the specified timepoints, up to 3 years

Results and safety

Results posted to the registry on 22 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)	40	0
Arm B: Lenalidomide + Dexamethasone	42	0

Primary outcome: 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). Number (70% Confidence Interval). Unit: Percentage of participants

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n = 40
Value	87.5 (79.7 to 92.9)

Population analysed: Participants treated with E-Ld

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)	26 of 40 (65%)	39 of 40 (97.5%)	2 of 40
Arm B: Lenalidomide + Dexamethasone	27 of 42 (64.3%)	42 of 42 (100%)	6 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32398792Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K. Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy. Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12. No abstract available.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Investigator Inquiry FormLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 28 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02272803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.