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Corticosteroid

Lenalidomide-Dexamethasone-DLI for Multiple Myeloma

Phase 2
Waitlist Available
Led By Jean Roy, MD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is a two-step treatment using Lenalidomide and Dexamethasone followed by Donor Leukocyte Infusions to offer an optimal disease control strategy in relapsed patients. The cytoreductive and immunomodulatory effects of Len are expected to induce a permissive immunological environment for the immunotherapeutic activity of DLIs to develop. This treatment combination has the potential to further improve depth of myeloma response, delay myeloma progression and improve patient survival.

Who is the study for?
This trial is for adults aged 18-65 with multiple myeloma in first relapse post-allogeneic stem cell transplant. Participants must not be pregnant, planning pregnancy, or breastfeeding and must follow strict contraception guidelines. They should have measurable disease but no recent participation in other drug trials, no early post-transplant relapse, no Lenalidomide resistance or active severe infections.Check my eligibility
What is being tested?
The study tests a two-step treatment combining Lenalidomide (Len) and Dexamethasone (Dex), followed by Donor Leukocytes Infusions (DLIs). This aims to control the disease after relapse from stem cell transplant by creating an environment that allows DLIs to work better while reducing the risk of graft-versus-host disease.See study design
What are the potential side effects?
Potential side effects include immune system complications like graft-versus-host disease due to DLIs, as well as risks associated with Lenalidomide and Dexamethasone such as blood clots, bone marrow suppression leading to low blood counts, increased risk of infections, allergic reactions and possibly organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My myeloma has returned after my first stem cell transplant.
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I agree to follow the pregnancy testing schedule as required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival
Secondary outcome measures
Disease status assessment by PET scan
Disease status assessment by flow cytometry
Evaluation of quality of life (QoL) during treatment
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide-Dexamethasone-DLIExperimental Treatment1 Intervention
Patients will receive Len (10 mg in the presence of ≤ grade I acute GVHD or absence of chronic GVHD; 5 mg in presence of controlled mild or moderate chronic GVHD) daily x 21 days with Dex 40 mg once weekly for a total of 6 cycles of 28 days each For grade ≥III non hematologic or grade IV hematologic toxicity, Len can be reduced to 5 mg In absence of these toxicities, acute GVHD (using Glucksberg modified criteria) or severe chronic GVHD (using NIH criteria), Len dose can be increased by 5 mg per cycle to a maximum of 25 mg If eligibility is confirmed, sibling and unrelated donor transplant recipients will both receive 3 donor lymphocyte infusions (DLIs) at the following doses: 5 x 106 CD3+/kg; 1 x 107 CD3+/kg; 5 x 107 CD3+/kg Patient will be followed for 5 years post relapse.

Find a Location

Who is running the clinical trial?

C3i Center Inc.UNKNOWN
Ciusss de L'Est de l'Île de MontréalLead Sponsor
68 Previous Clinical Trials
5,299 Total Patients Enrolled
2 Trials studying Multiple Myeloma
40 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
632 Previous Clinical Trials
127,910 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,853 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03413800 — Phase 2
Multiple Myeloma Research Study Groups: Lenalidomide-Dexamethasone-DLI
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03413800 — Phase 2
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03413800 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is the Lenalidomide-Dexamethasone-DLI protocol typically implemented?

"Ocular inflammation, empathetic response, inadequate responses to at least two previous chemotherapy protocols and branch retinal vein occlusion can be alleviated with the Lenalidomide-Dexamethasone-DLI medication regimen."

Answered by AI

Is the age limit of this research confined to those who are under 45 years of age?

"This clinical trial is open to patients who have attained the age of consent and are below 65 years old."

Answered by AI

Are there any openings available to join this clinical venture?

"For consideration in this medical trial, applicants must have been diagnosed with multiple myeloma and should be between 18 to 65 years old. Presently, around 10 participants are being sought."

Answered by AI

Has the Lenalidomide-Dexamethasone-DLI combination been given regulatory clearance by the FDA?

"Given the Phase 2 status of this study, our team at Power has assigned Lenalidomide-Dexamethasone-DLI a safety rating of 2 due to limited evidence that it is safe and effective."

Answered by AI

To what extent have Lenalidomide-Dexamethasone-DLI trials been conducted?

"At present, 696 medical studies are underway to analyze the efficacy of Lenalidomide-Dexamethasone-DLI. 166 trials have progressed into Phase 3 and while Mishawaka, Indiana is housing a large number of trials for this treatment option - 25489 locations worldwide are also conducting research on it's effectiveness."

Answered by AI

What is the size of the participant pool for this research endeavor?

"At the present moment, recruitment for this trial has been paused. Initially opening on February 12th 2018 and last edited on July 19th 2022, there are currently 1,039 trials actively recruiting patients with multiple myeloma and 696 studies utilizing Lenalidomide-Dexamethasone-DLI therapy that are accepting volunteers."

Answered by AI

Are there any opportunities for potential participants to join this experiment?

"Data hosted on clinicaltrials.gov displays that this specific medical trial is not actively looking for participants at the present moment, having been last edited in July 2019. Nevertheless, there are still 1735 other trials which are open to recruitment currently."

Answered by AI
~1 spots leftby Mar 2025