Expanded Access Treatment Protocol CA204-143
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02368301 |
|
Expanded Access Status :
No longer available
First Posted : February 23, 2015
Last Update Posted : March 21, 2022
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Myeloma | Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone |
| Study Type : | Expanded Access |
| Expanded Access Type : | Treatment IND/Protocol |
| Official Title: | An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
- Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone
Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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:
i)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.
ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE
Exclusion Criteria:
- 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)
- 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
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): NCT02368301
Show 27 study locations
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02368301 |
| Other Study ID Numbers: |
CA204-143 |
| First Posted: | February 23, 2015 Key Record Dates |
| Last Update Posted: | March 21, 2022 |
| Last Verified: | March 2022 |
|
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 |
Lenalidomide Elotuzumab 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 Immunologic Factors Angiogenesis Inhibitors |