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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

Must not have

Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity)

Presence of ≥ grade II or uncontrolled acute GVHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I do not have an active infection with HIV, HTLV-1 or 2, hepatitis B, or hepatitis C.

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I have moderate to severe or uncontrolled GVHD.

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I am a woman who could get pregnant and plan to try during or within 4 weeks after the study.

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My heart, lungs, or kidneys are not working well.

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I had a stem cell transplant from a donor after my own cells' transplant didn't work.

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I received Len therapy after a stem cell transplant, before any relapse.

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My condition did not improve with Len treatment before a stem cell transplant.

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I need assistance with my daily activities.

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I have severe or uncontrolled chronic GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

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

Primary study objectives

Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival

Secondary study objectives

Disease status assessment by PET scan

Disease status assessment by flow cytometry

Evaluation of quality of life (QoL) during treatment

+9 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: Lenalidomide-Dexamethasone-DLIExperimental Treatment1 Intervention

1. 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 1. For grade ≥III non hematologic or grade IV hematologic toxicity, Len can be reduced to 5 mg 2. 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 2. 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 3. Patient will be followed for 5 years post relapse.

0 / 12Eligibility criteria met