Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT00772915 | Completed Phase 2 Results DMC

• 6 other identifiers: CDR0000616057P30CA015083MC088408-002093NCI-2009-01201RV-MM-PI-367
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Rate at 12 Months

  PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl * Bone marrow plasma cell percentage (absolute increase of \>=10%)

  12 months from registration

Secondary Outcomes (4)

• Confirmed Response Rate

  Up to 18 cycles from registration

• Overall Survival (OS)

  Time from registration to death (up to 3 years)

• Progression-free Survival (PFS)

  Time from registration to progression or death (up to 3 years)

• Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)

  Duration on treatment (up to 18 cycles from registration)

Study Arms (1)

Lenalidomide with On-Demand Dexamethasone

EXPERIMENTAL

Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.

Drug: dexamethasone; Drug: lenalidomide

Interventions

dexamethasone DRUG

Dose: -40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression. If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle. If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly.

Lenalidomide with On-Demand Dexamethasone

lenalidomide DRUG

25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described).

Lenalidomide with On-Demand Dexamethasone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Newly diagnosed multiple myeloma, meeting the following criteria: * Symptomatic disease * Previously untreated disease * Measurable or evaluable disease, defined by ≥ 1 of the following: * Serum monoclonal protein ≥ 1.0 g/dL * Monoclonal protein \> 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * Measurable soft tissue plasmacytoma, not previously radiated * No monoclonal gammopathy of unknown significance or asymptomatic myeloma PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain) * ANC ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment * Registered into the RevAssist® program and willing to comply with program requirements * Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin * Willing to provide mandatory blood and bone marrow samples * Willing to return for follow up * No uncontrolled infection * No NYHA class III or IV heart failure * No active deep vein thrombosis that has not been therapeutically anticoagulated * No known hypersensitivity to thalidomide * No known HIV positivity * No known hepatitis type A, B, or C infection * No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy for solitary plasmacytoma * More than 28 days since other prior experimental drug or therapy * Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed * No prior lenalidomide * No prior cytotoxic chemotherapy * No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease * Prior corticosteroid for nonmalignant disease allowed * Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent) * Concurrent palliative radiotherapy for bone pain or fracture allowed * No other concurrent anticancer agents or treatments

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Dexamethasone; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Shaji Kumar
• Organization: Mayo Clinic

kumar.shaji@mayo.edu

Study Officials

• Shaji K. Kumar, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2008
• First Posted: October 15, 2008
• Study Start: December 3, 2008
• Primary Completion: March 22, 2011
• Study Completion: June 27, 2018
• Last Updated: January 18, 2020
• Results First Posted: August 8, 2012

Record last verified: 2018-06

Locations

US (1)