A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)

Conditions

• Monoclonal Gammopathy of Renal Significance
• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Days 1, 8 and 15, Cycles 1-8
• Bortezomib — DRUG
  Days 1,8,15, Cycles 1-8, Days 1,15 Cycles 9+
• Dexamethasone — DRUG
  Days 1,2,8, 9,15,16, 22, 23, Cycles 1-8
• Daratumumab — DRUG
  Days 1,8,15,22, Cycles 1-2, Days 1,15 Cycles 3-6, Day 1 Cycles 7+

Study Details

The purpose of this study is to find out whether cyclophosphamide, bortezomib, dexamethasone (CyBorD) with daratumumab SC is a safe treatment combination for MGRS-associated kidney disease including cast nephropathy associated with multiple myeloma. In addition, the researchers will find out whether the study drug combination is an effective treatment for these conditions.

Key Dates

Start date

Oct 16, 2023

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A will include patients with cast nephropathy
  Planned 8 cycles of CyBorD-Dara SC, treatment will be left to the discretion of the treating physician. It is recommended that patients eligible for ASCT undergo ASCT after 8 cycles of induction and that patient ineligible for ASCT, continue maintenance Bortezomib/Dexamethasone administered every other week with daratumumab SC administered every 4 weeks, for a period of 2 years from start of treatment.
• Experimental: Arm B will include all other MGRS associated diseases with the exclusion of AL amyloidosis
  Planned 8 cycles of CyBorD-Dara SC, treatment will be left to the discretion of the treating physician. It is recommended that patients eligible for ASCT undergo ASCT after 8 cycles of induction and that patient ineligible for ASCT, continue maintenance Bortezomib/Dexamethasone administered every other week with daratumumab SC administered every 4 weeks, for a period of 2 years from start of treatment.

Primary Outcome Measure

Run-in Phase- Dose-limiting toxicity (DLT) rates [ Time Frame: 2 years ]

Central Contacts

• Hani Hassoun, MD
  646-608-3718
  [email protected]
• Carlyn R Tan, MD
  646-608-3778

Locations (11)

Find similar trials in Boston, MA

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