A Study to Evaluate CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05519085 |
|
Recruitment Status :
Recruiting
First Posted : August 29, 2022
Last Update Posted : March 15, 2023
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Drug: CC-92480 Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 760 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) |
| Actual Study Start Date : | September 20, 2022 |
| Estimated Primary Completion Date : | November 3, 2025 |
| Estimated Study Completion Date : | November 30, 2033 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
| Experimental: 480Vd (CC-92480, bortezomib and dexamethasone) |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Bortezomib Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days
Other Names:
|
| Experimental: PVd (pomalidomide, bortezomib and dexamethasone) |
Drug: Pomalidomide
Specified dose on specified days
Other Names:
Drug: Bortezomib Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days
Other Names:
|
Primary Outcome Measures :
- Progression-free Survival (PFS) [ Time Frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years) ]
Secondary Outcome Measures :
- Recommended CC- 92480 dose [ Time Frame: Up to 12 Months ]Stage 1 only
- Plasma concentrations of CC-92480 [ Time Frame: Up to 134 Days ]Stage 1 only
- Overall Survival (OS) [ Time Frame: From date of randomization to date of death due to any cause (Up to approximately 5 years) ]
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]
- Percentage of participants with Complete Response Rate (CRR) or better as assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma [ Time Frame: Up to approximately 5 Years ]
- Percentage of participants with Very Good Partial Response Rate (VGPRR) or better as assessed by the IMWG Uniform Response Criteria for Multiple Myeloma [ Time Frame: Up to approximately 5 years ]
- Time to Response (TTR) [ Time Frame: Up to approximately 5 years ]
- Duration of Response (DOR) [ Time Frame: Up to approximately 5 years ]
- Time to Progression (TTP) [ Time Frame: Up to approximately 5 years ]
- Time to Next Treatment (TTNT) [ Time Frame: Up to approximately 5 years ]
- Progression-free Survival 2 (PFS-2) [ Time Frame: Up to approximately 5 years ]
- Minimal Residual Disease (MRD) negativity rate [ Time Frame: Up to approximately 5 years ]
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
- Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores [ Time Frame: Up to approximately 5 years ]The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.
- Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score [ Time Frame: Up to approximately 5 years ]The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.
Information from the National Library of Medicine
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 |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Participant has documented diagnosis of MM and measurable disease, defined as any of the following:
- M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or
- M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP)
- For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
- Participants received 1 to 3 prior lines of antimyeloma therapy.
- Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
Exclusion Criteria:
- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor.
- For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
- Participant has had prior treatment with CC-92480 or pomalidomide.
Other protocol-defined criteria apply.
Information from the National Library of Medicine
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): NCT05519085
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain the NCT# and Site #. |
Locations
Show 104 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT05519085 |
| Other Study ID Numbers: |
CA057-001 2021-001957-30 ( EudraCT Number ) |
| First Posted: | August 29, 2022 Key Record Dates |
| Last Update Posted: | March 15, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
|
Multiple myeloma RRMM 480Vd PVd CC92480 |
pomalidomide bortezomib dexamethasone mezigdomide |
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 |
Bortezomib Pomalidomide 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 |