Multiple MyelomaNCT02368301
Expanded Access Treatment Protocol CA204-143
A study testing Elotuzumab in combination with Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb.
Trial summary
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elotuzumab in combination with Lenalidomide and Dexamethasone
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Men and women 18 years and older.
- Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy.
- Prior lenalidomide exposure is permitted only if they fulfill all of the following:.
- Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.
- Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.
Who cannot join
- Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
- Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
- HIV infection or active hepatitis A, B, or C.
- History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009.
- Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD).
Show all 10Show fewer
- Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
- Certain abnormal physical or laboratory findings.
- Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein.
- Other protocol-defined Inclusion/Exclusion criteria apply.
About this study
Official title: An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab in combination with Lenalidomide and Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elotuzumab in combination with Lenalidomide and DexamethasoneDrug
Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368301
- Sponsor's protocol ID
- CA204-143
- Status last verified
- Nov 2023
- First submitted
- 6 Feb 2015
- Last updated
- 30 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02368301
- Acronym / sponsor ID
- CA204-143
- Conditions
- Multiple Myeloma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18 years and older.
- Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy.
- Prior lenalidomide exposure is permitted only if they fulfill all of the following:.
- Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.
Key exclusion criteria (10 listed)
- Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
- Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
- HIV infection or active hepatitis A, B, or C.
- History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009.
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 |
|---|---|---|
| Elotuzumab in combination with Lenalidomide and DexamethasoneElotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Multiple Myeloma
RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)
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
Questions about this trial
What is this clinical trial studying?
A study testing Elotuzumab in combination with Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 30 Nov 2023.