Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

Phase 3

Recruiting

• Conditions: Multiple myeloma,

• Registration Number: CTRI/2023/08/056910
• Lead Sponsor: BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED

Brief Summary

This study is a 2-stage, randomized, multicenter, open-label, Phase 3 study comparing the efficacy and safety of 480Kd versus Kd in participants with RRMM who received at least 1 prior line of therapy, including lenalidomide and an anti-CD38 mAb, however are carfilzomib naïve. Treatment will continue until confirmed PD, death, unacceptable toxicity, or withdrawal of consent. All participants will have an End of Treatment (EOT) visit to collect safety and efficacy assessments. Once the participant completes the end of treatment visit, they will enter the followup period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-09
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

• ï‚· Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following:  M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or  M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,  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 κ/λ FLC ratio.
• ï‚· Participant has received at least one prior line of anti-myeloma therapy.
• Note: One line can contain several phases (eg, induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
• ï‚· Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody.
• Note: Patients who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible.
• ï‚· Participant achieved minimal response [MR] or better to at least 1 prior anti-myeloma therapy.
• ï‚· Participant must have documented disease progression during or after their last antimyeloma regimen.

Exclusion Criteria

• Participant who has had prior treatment with CC-92480 or carfilzomib.
• Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
• Participant has any of the following laboratory values at screening: i.
• Absolute neutrophil count (ANC) < 1.0 × 109 /L (< 1,000/ μL) without growth factor support within 7 days prior to screening complete blood count (CBC) (14 days if pegfilgrastim is used) ii.
• Platelets < 75 × 109 /L (< 75,000/μL) and no platelet transfusions within the 7-day period leading up to screening CBC  Hemoglobin < 8 g/dL (< 4.9 mmol/L) iii.
• Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) iv.
• Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the progression free survival of	at baseline, 8 Months and until Progression free survival up to 5 years or study achieves endpoints
CC92480, carfilzomib & dexamethasone to that of carfilzomib and dexamethasone	at baseline, 8 Months and until Progression free survival up to 5 years or study achieves endpoints
in participants with relapsed or refractory multiple myeloma	at baseline, 8 Months and until Progression free survival up to 5 years or study achieves endpoints

Secondary Outcome Measures

Name	Time	Method
5. To evaluate additional efficacy parameters in	participants with RRMM treated with 480Kd compared to Kd
6. To evaluate additional efficacy parameters in	participants with RRMM treated with 480Kd compared to Kd
1. In Stage 1, to determine the dose of CC-92480 in	combination with carfilzomib & dexamethasone
4. To evaluate additional efficacy parameters in	participants with RRMM treated with 480Kd
10. In participants randomized to Stage 2 only, to evaluate cancer & multiple myeloma-related symptoms & health-related quality of life	(HRQoL) using the European Organization for
2. In Stage 1, to determine the plasma concentrations	of CC-92480 in combination with carfilzomib and
7. To evaluate additional efficacy parameters in	participants with RRMM treated with 480Kd
9. To evaluate safety of 480Kd compared to Kd in	participants with RRMM
3 To compare overall survival (OS) between 480Kd	and Kd in participants with RRMM
8. To evaluate minimal residual disease (MRD)	negativity rate in participants treated with 480Kd compared to those treated with Kd

Trial Locations

Locations (11)

Apollo Hospitals, (A Unit of Apollo Hospitals Enterprises Limited); 🇮🇳 Hyderabad, TELANGANA, India

Cancer Institute (W.I.A.); 🇮🇳 Chennai, TAMIL NADU, India

Healthcare Global Enterprises Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Kamineni Gem Care Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Max Super Speciality Hospital, Mohali; 🇮🇳 Rupnagar, PUNJAB, India

Medanta-The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Mumbai Oncocare Centre (Unit of cellcure cancer centre pvt Ltd); 🇮🇳 Thane, MAHARASHTRA, India

Post Graduate Institute of Medical Education & Research, Nehru Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 South, DELHI, India

Tata Memorial Hospital (Tata Memorial centre); 🇮🇳 Mumbai, MAHARASHTRA, India

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Apollo Hospitals, (A Unit of Apollo Hospitals Enterprises Limited)

🇮🇳Hyderabad, TELANGANA, India

Dr SVSS Prasad

Principal investigator

1204189500

svss.prasad@yahoo.co.in