Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635189
• Other study ID #: UMMY20033
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Jessica Ellis
• Phone: (585)275-2224
• Email: Jessica_Ellis[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

Description:

This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.

Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).

Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of multiple myeloma with diagnosis

• Must not have received previous therapy for multiple myeloma

• Newly diagnosed and not considered candidate for high-dose chemotherapy

• Adequate organ system function

• A performance status = 3

• Ability to swallow and retain oral medication

• Female subjects of child bearing potential must be surgically sterile, be post-menopausal

Exclusion Criteria:

• A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma

• A diagnosis of Waldenström's disease

• Receiving cancer therapy

• Radiation therapy within 14 days of enrollment

• Major surgery within 2 weeks before enrollment

• Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months

• Seropositive for hepatitis B, or seropositive for hepatitis C

• Ongoing systemic bacterial, fungal or viral infection

• Severe and/or uncontrolled medical conditions

• Malignancy within 2 years of study enrollment

• Women who are pregnant or lactating

• Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Daratumumab
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
• Lenalidomide
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
• Dexamethasone
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daratumumab Related Infusion Reactions	To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.	28 days
Secondary	Determination of Response Rates	To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen	28 days