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ATRA + Carfilzomib for Multiple Myeloma (ATRA Trial)

Phase 1 & 2

Recruiting

Led By Sai Ravi Pingali, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function defined as: Hemoglobin ≥8 g/dL (baseline or after Peripheral Red Blood Cell transfusion), Platelet count >75,000 and Absolute Neutrophil Count >1000/ micro liter, Left Ventricular Ejection fraction >50%, Creatinine Clearance ≥ 30 ml/min, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), Total bilirubin ≤ 1.5 × ULN

Age ≥ 18 years with relapsed/refractory multiple myeloma documented according to International Myeloma Working Group (IMWG) criteria

Must not have

Unstable angina pectoris, cardiac arrhythmia or > New York Heart Failure association class II cardiac failure, defined as comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain

Previous intolerance to a proteasome inhibitor, including carfilzomib, bortezomib, or ixazomib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever came first, assessed up to 7 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of combining two drugs, All-Trans Retinoic Acid (ATRA) and Carfilzomib, in treating Multiple Myeloma (MM

Who is the study for?

This trial is for patients with Multiple Myeloma, specifically those who have not responded to proteasome inhibitors. Participants should be adults likely over 55 years old, given the disease's prevalence in this age group.

What is being tested?

The study tests different doses of All-Trans Retinoic Acid (ATRA) combined with Carfilzomib on patients resistant to standard treatments. It aims to see if ATRA can make myeloma cells more sensitive to Carfilzomib.

What are the potential side effects?

Potential side effects include typical reactions from ATRA such as dry skin and lips, headaches, and bone pain; plus Carfilzomib's effects like fatigue, nausea, shortness of breath, and risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and my multiple myeloma has returned or is not responding to treatment.

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I had a stem cell transplant over 60 days ago and have recovered without needing ongoing treatment to help my blood counts.

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I've had 3 treatments with carfilzomib and others but didn't improve after 2 cycles or my condition worsened during treatment.

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I can perform all self-care but may not be able to work.

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I have measurable disease markers indicating I need treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart issues that limit my daily activities.

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I have had a bad reaction to a proteasome inhibitor treatment.

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My multiple myeloma shows low or no M-protein in blood or urine tests.

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I have been diagnosed with plasma cell leukemia.

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I have been diagnosed with light chain amyloidosis.

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I am allergic or intolerant to Carfilzomib-based treatments.

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I have had a bone marrow or organ transplant.

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I have a health condition or social situation that might affect my study participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever came first, assessed up to 7 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever came first, assessed up to 7 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever came first, assessed up to 7 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability of ATRA in combination with Carfilzomib/ Dexamethazone and RP2D

Secondary study objectives

Disease response as measured by serum, viable cryopreserved peripheral blood mononuclear cells, and bone marrow myeloma plasma cells.

Duration of Response of combination therapy of ATRA, Carfilzomib, and Dexamethasone in resistant Multiple Myeloma

Efficacy of combination therapy of ATRA, Carfilzomib, and Dexamethasone in resistant Multiple Myeloma

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All-Trans Retinoic Acid (ATRA), Carfilzomib, and DexamethasoneExperimental Treatment3 Interventions

Carfilzomib will be given at Cycle 1 (20 mg/m2 on Days 1, 70 mg/m2 on Days 8 and 15) and Cycles 2 - onward (70 mg/m2 on Days 1, 8, and 15) as a 30-minute intravenous (IV) infusion to evaluate tolerability to treatment. Dexamethasone will be given \[20 mg, PO/IV\] on the days of carfilzomib treatment. ATRA will be given for 3 weeks (21 days) out of every 4 weeks (28 days) up to a maximum of 24 weeks (6 cycles). Only for Cycle 1, patients will start oral ATRA 25 mg/m2 7 days prior to Cycle 1 Day 1 through Cycle 1 Day 21 for a total of 28 days of dosing. To assign a dose to the next cohort of patients, dose escalation/de-escalation according to the trials Bayesian Optimal Interval (BOIN) Design is conducted. In patients who respond and do not have any dose limiting toxicity (DLT), treatment will continue for a total of 6 cycles in the phase II expansion cohort and subsequently transitioned to standard -of-care options.

0 / 14Eligibility criteria met