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Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure

ConditionMyeloma Multiple
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Cooperative Oncology Group

About this trial

This study is being done to answer the following question:

Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.

If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles).

After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.

Anemia (hemoglobin value of >2 g/dL below the lower limit of normal, or a hemoglobin value <10 g/dL)

Hypercalcemia (serum calcium >1 mg/dL higher than the upper limit of normal or >11 mg/dL)

Bone disease (one or more osteolytic lesions on skeletal radiography, CT, or FDG-PET/CT)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Arm A

  • Bortezomib (VELCADE)

    Drug

    Arm A, Arm B

  • Dexamethasone

    Drug

    Arm A, Arm B

  • Daratumumab-hyaluronidase

    Drug

    Arm B

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: ARM A (Cy-Bor-Dex)Active comparator 3 interventions
Group B: ARM B (Dara-Bor-Dex)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Renal Response Rate

Renal response rate (RRR) is the proportion of patients achieving complete or partial renal response based on International Myeloma Working Group (IMWG) renal response criteria (Dimopoulos 2023) over 4 cycles of treatment.

Time frame
Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)

Secondary outcomes

1

Grade 3-5 Overall Toxicity Rate

Grade 3-5 overall toxicity rate is the proportion of participants who experience a maximum grade 3-5 treatment-related adverse event (AE) based on the Common Toxicity Criteria for Adverse Events Version 5.0 (CTCAEv5).

Time frame
Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)
2

Grade 3-5 Non-Hematologic Toxicity Rate

Grade 3-5 non-hematologic toxicity rate is the proportion of participants who experience a maximum grade 3-5 treatment-related non-hematologic AE based on CTCAEv5.

Time frame
Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)
3

Grade 3-5 Hematologic Toxicity Rate

Grade 3-5 hematologic toxicity rate is the proportion of participants who experience a maximum grade 3-5 treatment-related hematologic AE based on CTCAEv5.

Time frame
Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)
4

Best Response

Best response is the frequency of participants achieving stringent complete response (sCR), complete response (CR), partial response (PR), stable disease (SD) or disease progression (PD) based on International Myeloma Working Group (IMWG) uniform response criteria (URC; Durie 2006) over 4 cycles of treatment.

Time frame
Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Cooperative Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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