Myeloma Vaccine + Lenalidomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen bySyed A Ali, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study seeks to determine whether addition of an allogeneic myeloma vaccine can augment clinical responses to lenalidomide in patients with near complete remission (nCR), or complete remission (CR) leading to a significant improvement in progression-free survival.This main objective of this study is to compare the 2-year progression free survival of patients with multiple myeloma in CR or nCR, treated with lenalidomide plus an allogeneic myeloma vaccine in combination with lenalidomide (with or without Prevnar vaccine) or versus placebo in combination with lenalidomide (control arm).

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma in complete or near complete remission, currently on Revlimid therapy. They must not have high-risk myeloma features, HIV, active infections needing treatment, or other recent investigational drug use. Women must follow strict pregnancy prevention measures and men agree to use condoms.

Inclusion Criteria

You have a history of specific proteins in your blood or urine.

Your absolute neutrophil count is above 1000 per microliter.

You are expected to live for at least 12 more months.

+23 more

Exclusion Criteria

Patients who have participated in any clinical trial, within the last four weeks, which involved an investigational drug

I have been diagnosed with POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma, or amyloidosis.

I do not have HIV or any active infections needing treatment within the last 2 weeks.

+7 more

Participant Groups

The study tests if adding an allogeneic myeloma vaccine improves the effectiveness of lenalidomide in patients who are already responding well to treatment. It compares progression-free survival between those receiving the vaccine plus lenalidomide and those given a placebo with lenalidomide.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Lenalidomide plus GM-CSF Vaccine plus Prevnar13Experimental Treatment3 Interventions

Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Prevnar vaccine will be administered with the GM-CSF vaccine administration.

Group II: Lenalidomide plus GM-CSF VaccinePlacebo Group3 Interventions

Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Patients will also be administered a placebo prevnar13 vaccination. Placebo will be saline.

Group III: Lenalidomide OnlyPlacebo Group3 Interventions

Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients will also get placebo GM-CSF vaccine and placebo prevnar13. Placebo will be saline.