CompletedPhase 1/2

Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma

United States54 participantsStarted 2004-11

Plain-language summary

RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment choice for destroying myeloma cells, especially when given at high (bone marrow ablative) doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT) given after either melphalan or following TMI (aimed at the bone marrow containing areas of the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an effective agent on its own right for the treatment of myeloma, has been shown to further enhance the beneficial effects of autologous stem cell transplants when given as maintenance therapy. PURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy. The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific emphasis on assessing complete and very good partial response rate conversions, progression-free and overall survival, and safety/feasibility of delivering the planned treatment regimen.

Who can participate

Age range70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Criteria * Patients with multiple myeloma (stages I-III) will be eligible if they are either in response, or have stable disease * Patients with smoldering myeloma are eligible if there is evidence of progressive disease requiring therapy (\>= 25% increase in M protein levels or Bence Jones excretion; Hgb =\< 10.5 g/dl; frequent infections; hypercalcemia; rise in serum creatinine above normal on two separate occasion) * Patients with non-quantifiable monoclonal proteins are eligible provided they meet other criteria for multiple myeloma, or smoldering myeloma, and they have evaluable or measurable disease by other (radiographic) means * Unlimited prior chemotherapy regimens allowed * KPS \>= 70% * Patients with Waldenstrom's macroglobulinemia are not eligible * Less than 18 months since diagnosis * No contraindication to the collection of a minimum of 4 x 10\^6 CD34+ cells/kg by apheresis * All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines * Adequate hepatic function as demonstrated by bilirubin, =\< 1.5 mg/dl, and SGOT and SGPT \< 2.5 x upper limits of normal * Adequate renal function as demonstrated by: creatinine of measured or calculated creatinine clearance of \> 50 cc/min * Absolute neutrophil count of \> 1000/ul, platelet count of \> 100,000/ul * Cardiac ejection fraction \>= 50% by MUGA scan and/or by echocardiogram * Adequate pulmonary function as demonstrated by FEV1 \> 60% and DLCO \> 50% of predict…

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: 8 weeks from start of treatment, up to 2 years

Number of Subjects With Response

Timeframe: Evaluated after each course until completion of treatment.

Overall Survival

Timeframe: From date of treatment until the date of death from any cause, assessed up to 14 years

Trial details

NCT IDNCT00112827

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-15

Results submitted2020-09-21

View on ClinicalTrials.gov More Refractory Multiple Myeloma trials