Actively Recruiting
VitD3 Supplementation in Patients With Multiple Myeloma
Led by Amany Keruakous, MD, MS. · Updated on 2025-04-08
100
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.
CONDITIONS
Official Title
VitD3 Supplementation in Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older at registration.
- History and physical exam within 28 days before registration.
- Zubrod/ECOG Performance Status of 0, 1, or 2.
- Confirmed diagnosis of symptomatic multiple myeloma with measurable disease requiring systemic induction therapy prior to ASCT.
- Willing and able to take blood clot prevention medications and comply with lenalidomide REMS requirements.
- Females of childbearing potential must have negative pregnancy tests before starting lenalidomide and agree to use two forms of birth control or abstain from heterosexual intercourse.
- Males must agree to use a latex condom during sexual contact with females of childbearing potential during and for 3 months after treatment.
- Adequate kidney function with creatinine clearance ≥10 mL/min.
- Adequate liver function: total bilirubin ≤1.5 times upper normal limit, AST and ALT ≤3 times upper normal limit.
- Acceptable for transplant per institutional guidelines.
- Patients with HIV are eligible if on effective therapy with undetectable viral load.
- Able to swallow oral capsules.
- Must provide informed consent.
You will not qualify if you...
- Amyloidosis with organ involvement or related organ dysfunction.
- Progressive disease before registration.
- Intolerance to starting dose of lenalidomide (10 mg).
- Prior allograft, organ transplant requiring immunosuppression, or previous autologous transplantation.
- Prior malignancy except certain treated skin cancers, in situ cervical cancer, or cancers in remission for at least 3 years.
- Received investigational agents within 14 days prior to registration.
- Positive for Hepatitis B or C.
- Hypercalcemia (serum calcium >10.3 mg/dL) at study entry.
- Refractory to lenalidomide.
- Known gastrointestinal conditions affecting drug absorption.
- Known allergies to study drugs.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
K
Kelly Jenkins, MSN, RN
CONTACT
G
GCC Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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